BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREBOA-PRO CATHETER

    MDR report key: 12584062 · Received October 6, 2021

    Report

    Report Number
    3012279212-2021-00002
    Event Type
    Injury
    Date Received
    October 6, 2021
    Date of Event
    September 3, 2021
    Report Date
    October 6, 2021
    Manufacturer
    PRYTIME MEDICAL DEVICES INC.
    Product Code
    MJN
    PMA / PMN Number
    K200459
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    ON (B)(6) 2021 PRYTIME WAS INFORMED THAT A PHYSICIAN WAS UNABLE TO REMOVE THE PREBOA-PRO CATHETER FROM THE INTRODUCER SHEATH. THE PHYSICIAN PERFORMED A SURGICAL CUT DOWN ON THE VESSEL TO REMOVE THE CATHETER AND SHEATH TOGETHER AS ONE UNIT. REMOVAL OF THE CATHETER AND SHEATH AS A UNIT CAUSED BLEEDING FROM GROIN. THE PHYSICIAN REPAIRED THE SITE. THE PHYSICIAN STATED THE REPAIR WAS FINE AFTER A DAY OR SO. PHYSICIAN WAS NOT SURE WHAT CAUSED THE REMOVAL ISSUE. PHYSICIAN DID NOT THINK IT WAS A MALFUNCTION OF THE CATHETER. THE PHYSICIAN STATED THE SURGICAL CUT DOWN WAS THE ONLY OPTION HE HAD TO REMOVE THE CATHETER AT THE TIME. HE DID NOT HAVE TIME TO TROUBLE SHOOT THE REMOVAL ISSUE BECAUSE THE PATIENT WAS TOO SICK. THE PATIENT WAS STRUCK BY A MOTOR VEHICLE, SUFFERED BLUNT CARDIAC INJURY, PATIENT'S CHEST AND PELVIS WERE CRUSHED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1481766 PREBOA-PRO CATHETER CATHETER, INTRAVASCULAR OCCLUDING, TEMPORARY MJN PRYTIME MEDICAL DEVICES INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention