BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PREBOA-PRO CATHETER

    MDR report key: 17608098 · Received August 23, 2023

    Report

    Report Number
    3026788751-2023-00011
    Event Type
    Injury
    Date Received
    August 23, 2023
    Date of Event
    July 22, 2023
    Report Date
    August 23, 2023
    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
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THREE FACTORS MAY HAVE PLAYED A ROLE IN THE TECHNICAL DIFFICULTIES SUMMARIZED ABOVE. ONE, IT IS UNKNOWN WHETHER ALL FLUID WAS COMPLETELY REMOVED FROM THE BALLOON PRIOR TO ATTEMPTED REMOVAL. AS NOTED IN THE IFU, FAILURE TO REMOVE ALL FLUID FROM THE BALLOON PRIOR TO ATTEMPTED REMOVAL MAY MAKE IT DIFFICULT OR IMPOSSIBLE TO REMOVE THE CATHETER FROM THE INTRODUCER SHEATH AND/OR VESSEL. THE SECOND IS THE PROCESS STEPS IN WHICH THE CATHETER AND SHEATH WERE REMOVED. AGAIN, PER OUR IFU, "IF DIFFICULTY IS ENCOUNTERED WHEN REMOVING THE CATHETER, REMOVE THE CATHETER AND INTRODUCER SHEATH AS A UNIT." DURING THIS CASE, THE SHEATH WAS REMOVED FIRST, THEN THE CATHETER BALLOON WAS REMOVED; THESE INDIVIDUAL STEPS MAY HAVE CAUSED A LARGER OPENING AT THE ACCESS SITE, THUS REQUIRING SURGICAL INTERVENTION FOR CLOSURE. LAST, THE SURGEON MADE NOTE OF THE PATIENT'S LARGE SIZE, WHICH MAY HAVE CREATED A TORTUOUS PATH FOR THE SHEATH AND THE CATHETER BALLOON DURING REMOVAL.

    Description of Event or Problem · 0

    PRYTIME IS FILING THIS REPORT WITH AN ABUNDANCE OF CAUTION AS THE REBOA CATHETER WAS PRESENT DURING A CASE THAT REQUIRED SURGICAL REPAIR OF THE LEFT FEMORAL ARTERY AFTER REMOVAL. THE CASE INVOLVED A FEMALE PATIENT WHO WAS TRANSFERRED FROM ANOTHER FACILITY (VIA AIR) AND SHORTLY AFTER ARRIVAL SHE ARRESTED. THE PATIENT WAS PRESENTED WITH AN UNSTABLE PELVIC FRACTURE (PELVIC BINDER IN PLACE) AFTER BEING INVOLVED IN A MOTORCYCLE ACCIDENT. THE TRAUMA TEAM PLACED A REBOA CATHETER IN THE LEFT GROIN AND INFLATED IT WITH 8CC OF FLUID. AFTER OPERATING PROCEDURES WERE COMPLETED, THE CATHETER BALLOON WAS DEFLATED AND PREPARED FOR REMOVAL. DURING THE ATTEMPTED REMOVAL OF THE CATHETER BALLOON, THE VASCULAR SURGEON REPORTED MEETING AN UNUSUAL AMOUNT OF RESISTANCE. HE STATED HE PERFORMED ALL REQUIRED STEPS FOR THE REMOVAL PROCESS AND STILL MET RESISTANCE. HE PLACED A 0.018 STAINLESS-STEEL WIRE, THEN REMOVED THE SHEATH AND THEN REMOVED THE CATHETER. A NEW SHEATH WAS PLACED. HE NOTICED SOME LEAKAGE AROUND THE SHEATH AND DECIDED TO PERFORM AN ADDITIONAL ANGIOGRAM WHICH REVEALED BLEEDING AROUND THE FEMORAL ARTERY (LATERAL SIDE OF THE ARTERY). WITH THE PATIENT BEING OF LARGE SIZE, THE VASCULAR SURGEON ELECTED TO DO A CUTDOWN ON THE LEG VERSUS PULLING THE SHEATH AND APPLYING PRESSURE (AS THE PATIENT HAD ALREADY ARRESTED TWICE). THE SURGEON ADVISED IT WAS AN EASY EXPOSURE OF THE FEMORAL ARTERY; A CLAMP WAS PLACED ABOVE AND BELOW THE SHEATH. THE SHEATH WAS REMOVED, THEN THE WIRE WAS REMOVED, AND THE SURGEON REPAIRED THE ARTERY WITH 2 OR 3 SUTURES. UPON INVESTIGATION OF THIS INCIDENT, ADDITIONAL INFORMATION COULD NOT BE GATHERED AS THE DEVICE WAS NOT RETAINED AND DELIVERED TO PRYTIME FOR ANALYSIS. OVERALL, THERE WAS NO CONFIRMED DEFICIENCY WITH THE PRYTIME PRODUCT EXHIBITED IN THIS CASE. IN ADDITION, THERE IS NO REPORTED OR ALLEGED FAILURE OR DEFICIENCY OF THE PRYTIME CATHETER OR ITS LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    311680 PREBOA-PRO CATHETER Catheter, intravascular occluding, temporary MJN PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention