Cardiovascular · 510(k) · 2023
Saranas Early Bird Bleed Monitoring System
Saranas Inc.. Cleared by FDA on 25 May 2023 under submission K230273, product code QFJ (intravascular bleed monitor). What FDA's record says, in FDA's words.
Device record · K230273
- Device. Saranas Early Bird Bleed Monitoring SystemDEVICE
- Company. Saranas Inc.COMPANY
- Decision. 25 May 2023, 510(k), substantially equivalent (traditional review); received 31 January 2023DECISION
- Panel. CardiovascularPANEL
- Product code. QFJ, Intravascular Bleed MonitorCODE
- Regulation. 21 CFR 870.1345, Class IIREG
- Source. FDA database entry · decision document (9 pages)SOURCE
Retrieved · the fields above are FDA's; the statement below was copied from the decision document on that day.
What FDA cleared it for
The Indications for Use statement, verbatim, from the decision document.
The Early Bird is indicated for the introduction of catheters, catheter balloons, and other diagnostic and interventional devices into the femoral artery or femoral vein while maintaining hemostasis during diagnostic and interventional endovascular procedures. The Early Bird provides physicians with an early indication of a potential internal bleeding complication by initial detection and monitoring of extravascular fluid accumulation.
The product code's definition, from FDA's classification record. An intravascular bleed monitor is a probe, catheter, or catheter introducer that measures changes in bioimpedance and uses an algorithm to detect or monitor progression of potential internal bleeding complications.
What the statement says
Pattern matches on the Indications for Use text. Each line is a fact that the text contains the words, not a finding about the device.
- Mentionsdetection or identification of findings
- Mentionsa diagnostic claim
Adverse-event reports in MAUDE, by product code
As of , MAUDE held 3 reports filed against devices carrying product code QFJ. That code is shared by every device of this type, not this device alone, and MAUDE reports are submitted by manufacturers, facilities and the public without FDA verification. The latest reports, in the reporter’s words:
26 February 2023 · Death · EARLY BIRD BLEED MONITORING SYSTEM · SARANAS, INC. · report 3016011241-2023-00001
DURING THE LARGE-BORE 16F SHEATH REMOVAL AND WIRE EXCHANGE, THE FIRST EARLY BIRD LEVEL 1 INDICATION WAS TRIGGERED. SHORTLY THEREAFTER, THE PATIENT'S PRESSURE DROPPED SIGNIFICANTLY, AND IT WAS DETERMINED AT THAT TIME THAT THE PATIENTS RIGHT COMMON ILIAC WAS PERFORATED. DR. (B)(6) AND STAFF BEGAN APPLYING PRESSURE WHILE THEY ASSESSED. DR. (B)(6) THEN PLACED 3 ATRIUM ILIAC COVERED STENTS TO REPAIR THE RIGHT COMMON ILIAC; THIS TOOK ROUGHLY 8-10 MINUTES. AN ANGIOGRAM WAS PERFORMED TO CONFIRM THE […]
26 February 2023 · Injury · EARLY BIRD BLEED MONITORING SYSTEM · SARANAS, INC. · report 3016011241-2023-00002
A BLEED IN THE CONTRALATERAL RETROPERITONEAL SPACE DID NOT TRIGGER A LEVEL 1 BLEED INDICATION IN THE EARLY BIRD DEVICE. A PRODUCT EXPERIENCE REPORT WAS CREATED TO DOCUMENT THIS CASE AS AN INQUIRY ONLY BY THE INTERVENTIONIST. THE INTERVENTIONIST DID NOT INITIALLY PROVIDE ANY DATA REGARDING THE CASE OR PATIENT AS HIS INTEREST WAS IN THE BIOIMPEDANCE SIGNAL AS IT RELATED TO THIS CONTRALATERAL BLEED. THIS EVENT DID NOT TRIGGER A COMPLAINT; THE EARLY BIRD DEVICE IS NOT INTENDED TO DETECT […]
16 January 2023 · Injury · EARLY BIRD BLEED MONITORING SYSTEM · SARANAS, INC. · report 3016011241-2022-00001
THE EVENT OCCURRED ON (B)(6) 2022 AT (B)(6). THE COMPLAINT WAS RECEIVED ON OCTOBER 6, 2022 BY THE SARANAS SALES REPRESENTATIVE WHO WAS NOT PRESENT AT THE CASE. THE FACILITY REPORTING PERSON INDICATED THAT PRIOR TO THE PROCEDURE, THE SARANAS EARLY BIRD BLEED MONITORING SYSTEM (8FR) WAS PREPARED AT THE SCRUB TABLE PER THE INSTRUCTIONS FOR USE (IFU). THE EARLY BIRD BATTERY ISOLATION PULL TAB WAS REMOVED TO ACTIVATE THE DEVICE, AND A GREEN BLINKING LIGHT WAS OBSERVED ON THE DEVICE USER INTERFACE […]
Where this fits
This page is a record, not medical advice and not a safety rating. It copies FDA's fields and FDA's statement, and lists what the statement's text mentions. Read the labeling before relying on any of it.
More devices under product code QFJ, in Cardiovascular, or cleared in 2023. The whole record is at FDA AI-enabled medical devices.
A device's authorized use is a sentence the record can be read against. What Apodicta does on a medical record is that reading: every line of a note, a claim or a report proved to its source or held, before it renders.