BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREBOA-PRO CATHETER

    MDR report key: 14649178 · Received June 9, 2022

    Report

    Report Number
    3014034613-2022-00003
    Event Type
    Injury
    Date Received
    June 9, 2022
    Date of Event
    May 8, 2022
    Report Date
    June 9, 2022
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    MJN
    PMA / PMN Number
    K200459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRYTIME IS FILING THIS REPORT IN AN ABUNDANCE OF CAUTION BECAUSE A SURGICAL CUTDOWN OF THE COMMON FEMORAL ARTERY WAS NECESSARY TO REMOVE A REBOA CATHETER BALLOON WHICH SNAGGED ON ILIAC ARTERY CALCIFICATION WITHIN A PATIENT. THERE WAS NO REPORTED OR ALLEGED FAILURE OF THE PRYTIME DEVICE OR ITS LABELING. THE TRAUMA SURGEONS STATED THAT THE CUTDOWN WAS NECESSARY FOR REMOVAL OF THE CATHETER, AND THE CUTDOWN WAS LIKELY UNAVOIDABLE DUE TO THE PATIENT'S CALCIFICATION. PRYTIME WAS NOTIFIED OF THE EVENT ON MAY 13, 2022. PATIENT WAS 59-YEAR-OLD MALE THAT WAS INVOLVED IN AN AUTOMOBILE VERSUS BICYCLE ACCIDENT. THE PATIENT WAS INTUBATED IN THE FIELD AND HYPOTENSIVE ON EMERGENCY DEPARTMENT ARRIVAL. MASSIVE TRANSFUSION PROTOCOL WAS INITIATED ON ARRIVAL. CHEST RADIOGRAPHY SHOWED BILATERAL PNEUMOTHORAXES, AND CHEST TUBES WERE PLACED BILATERALLY. THE PATIENT HAD SUBCUTANEOUS EMPHYSEMA FROM HIS THIGHS TO HIS HEAD. RIGHT COMMON FEMORAL ARTERIAL (CFA) ACCESS WAS GAINED BY THE ATTENDING PHYSICIAN VIA AN INTRODUCER SHEATH, AND REBOA CATHETER WAS INSERTED AND INFLATED WITHOUT ANY ISSUES. ONCE THE PATIENT WAS STABLE ENOUGH FOR CT SCAN, THE BALLOON WAS DEFLATED. THE SURGEON HAD DIFFICULTY REMOVING THE BALLOON FROM THE INTRODUCER SHEATH AND CONTACTED VASCULAR SURGERY. THE VASCULAR TEAM THEN PERFORMED A CUTDOWN OF THE COMMON FEMORAL ARTERY TO REMOVE THE CATHETER AND SHEATH AND NOTED THAT THE BALLOON WAS SNAGGED ON ILIAC ARTERY CALCIFICATION, WHICH HAD PREVENTED REMOVAL OF THE BALLOON. THE SURGEONS COMMENTED THAT THE USE OF THE PREBOA PRO IN THE PROCEDURE ALLOWED THIS PATIENT TO AVOID AN EXPLORATORY LAPAROTOMY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2145616 PREBOA-PRO CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY, PRODUCT CODE: MJN MJN PRYTIME MEDICAL DEVICES, INC. PREBOA-PRO

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention