BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ER-REBOA PLUS CATHETER

    MDR report key: 20131170 · Received September 3, 2024

    Report

    Report Number
    3026788751-2024-00011
    Event Type
    Injury
    Date Received
    September 3, 2024
    Date of Event
    July 21, 2024
    Report Date
    September 3, 2024
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    MJN
    UDI-DI
    00850001105057
    PMA / PMN Number
    K193440
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USER RESPONSIBLE PERSON IDENTIFIED A LACK OF TRAINING AS A FACTOR IN THE INCIDENT. THE INDIVIDUAL IN CHARGE OVERINFLATED THE BALLOON IN A PATIENT WITH SMALL VASCULATURE. 20ML OF FLUID WAS USED TO INFLATE THE BALLOON RATHER THAN THE RECOMMENDED 2ML IN THE IFU. DISTAL BLOOD PRESSURE MEASUREMENTS OR IMAGING WERE NOT USED TO CONFIRM OCCLUSION. IFU STATES "OVER-INFLATION OF THE BALLOON MAY RESULT IN DAMAGE TO VESSEL WALL AND/OR VESSEL RUPTURE AND/OR BALLOON RUPTURE AND/OR CATHETER DAMAGE". THIS WAS A ZONE 3 PLACEMENT; THEREFORE, THE RECOMMENDED INFLATION VOLUME PER THE IFU IS 2CC. THE VASCULAR SURGEON THAT REPAIRED THE VESSEL STATED THAT STARTING WITH 2CC WOULD HAVE BEEN THE APPROPRIATE STARTING INFLATION VOLUME FOR THIS PATIENT. THE TABLE BELOW WITH INFLATION VOLUMES IS TRANSCRIBED FROM THE IFU: BALLOON DIAMETER: INFLATION VOLUME: 9MM , 2CC, 15MM , 5CC, 20MM , 8CC, 25MM , 13CC, 30MM, 20CC, 32MM (MAX). 24CC (MAX). ADDITIONAL TRAINING HAS BEEN SCHEDULED WITH THE FACILITY.

    Description of Event or Problem · 0

    PLACENTA PRAEVIA TOTALIS PERCRETA PATIENT WAS ORIGINALLY PLANNED FOR A C-SECTION WITH ELECTIVE USE OF THE REBOA THROUGH A SPECIAL TEAM EXPERIENCED IN ENDOVASCULAR PROCEDURES. BLEEDING AND WORSENING OF THE CHILD'S PERFUSION LED TO AN UNPLANNED, URGENT C-SECTION WITH BLOOD LOSS GREATER THAN 2.5 LITERS. THE CONSULTANT IN CHARGE DECIDED TO USE THE ER-REBOA PLUS CATHETER. THE INITIAL PLACEMENT OF THE 7FR SHEATH WAS UNEVENTFUL. THE CONSULTANT HAD A FORMAL TRAINING SESSION FOR REBOA, BUT IN THIS CASE HE DIDN'T USE A DISTAL BP MEASUREMENT NOR DID HE USE THE RECOMMENDED OCCLUSION VOLUME (2CC). HE USED 20CC FOR INFLATING THE BALLOON. AFTER OCCLUDING THE AORTA IN ZONE III, IT LED TO GOOD OPERATION CONDITIONS FOR THE OBS. AFTER FINISHING THE OPERATION, THE TEAM TRIED TO DEFLATE THE BALLOON, WHICH WAS FOLLOWED WITH A PROFOUND HEMODYNAMICALLY INSTABLE SITUATION. THE REASON WAS A RUPTURED RETROPERITONEAL AORTA (LESION 4CM VENTRALLY, AT THE BALLOON POSITION). AORTA WAS SUTURED AND A PATCH WAS USED. AS OF (B)(6) 2024, PATIENT WAS AT HOME AND IN GOOD HEALTH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1079743 ER-REBOA PLUS CATHETER Catheter, intravascular occluding, temporary MJN PRYTIME MEDICAL DEVICES, INC. 00850001105057

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention