BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 19781856 · Received July 19, 2024

    Report

    Report Number
    3026788751-2024-00010
    Event Type
    Injury
    Date Received
    July 19, 2024
    Date of Event
    June 20, 2024
    Report Date
    July 15, 2024
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    OFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH AND REBOA CATHETER, WHICH MAY HAVE CONTRIBUTED TO A THROMBUS REQUIRING SURGICAL INTERVENTION FOR REPAIR. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THE PREBOA-PRO CATHETER IS A PRYTIME MANUFACTURED DEVICE. THE CASE INVOLVED A PATIENT WITH GUN SHOT WOUNDS TO THE RIGHT LOWER QUADRANT AND RIGHT GROIN. LEFT CFA ACCESS WAS ACHIEVED USING ULTRASOUND, AND THE SURGEON ELECTED TO USE REBOA FOR TIME TO GET TO CT TO IDENTIFY INJURIES. THE ACCESS LINE WAS UPSIZED USING THE REBOA CATHETER CONVENIENCE KIT, AND THE PREBOA-PRO CATHETER WAS PLACED IN ZONE 1. THE INITIAL INFLATION WAS TO NEARLY FULL OCCLUSION - SBPS HYPERTENSIVE TO 200S. THE BALLOON WAS THEN DEFLATED TO SBPS OF 110S, AND WHEN THE BALLOON TAKEN BACK TO PARTIAL OCCLUSION, ARTERIAL BLOOD SHOT OUT OF R GROIN BULLET HOLE, WHICH ALERTED THE SURGEON TO ARTERIAL INJURY AT THIS SITE. THE SURGEON THEN OPTED TO GO STRAIGHT TO OR WITH VASCULAR FOR R CFA ARTERIAL REPAIR. AS VASCULAR REPAIRED R GROIN ARTERIAL AND VENOUS INJURIES PRIMARILY, THE TRAUMA SURGEON PERFORMED EX LAP. REBOA KEPT SURGICAL FIELD CLEAR WITH NO ABDOMINAL BLEEDING IDENTIFIED. THE CATHETER BALLOON WAS DEFLATED SLOWLY IN OR AND PATIENT WAS STABLE. THE DEFLATED REBOA LEFT IN PLACE FOR 90MIN TOTAL TIME TO FINISH THE PROCEDURE. WHILE STILL IN OR PATIENT NOTED TO HAVE NO PULSES IN L FOOT WHILE THE SHEATH WAS STILL IN PLACE. WHEN THEY NOTED THE PATIENT HAD DECREASED OR NO LEFT LOWER EXTREMITY PULSES, THEY ATTEMPTED TO PALPATE MORE PROXIMAL PULSES (ILIACS) AND NOTED THEY WERE ABSENT AS WELL. KNOWING THIS, THEY ASSUMED THE THROMBUS IS EITHER IN THE ILIACS (POSSIBLY AT THE END OF THE SHEATH) OR UP HIGHER IN THE AORTA (POSSIBLY ON THE END OF THE REBOA CATHETER). VASCULAR PERFORMED A CUTDOWN AT THE ACCESS SITE FOR A THROMBECTOMY USING SUCTION AND FLOATING INTO THE CFA, UP INTO THE ILIAC ARTERIES AND THE AORTA SO IT IS UNCLEAR EXACTLY WHERE THE THROMBUS WAS PULLED FROM. DESPITE THE EXTRA PROCEDURE OF CUT DOWN AND THROMBECTOMY- WHICH ALL HAPPENED DURING THE INITIAL OR CASE, THE PATIENT EXPERIENCED NO INJURY OR LASTING EFFECTS. PULSES RETURNED AND NO DEFICITS NOTED ON FOLLOW UP EXAMS. USER STATED THEY DID NOT FLUSH THE SHEATH OR CATHETER EVERY 15 MINUTES PER THE IFU STEPS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1555012 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention