BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 23833459 · Received December 17, 2025

    Report

    Report Number
    3026788751-2025-00005
    Event Type
    Injury
    Date Received
    December 17, 2025
    Date of Event
    November 26, 2025
    Report Date
    December 17, 2025
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    OFC
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    PHYSICIAN REPORTED DIFFICULTY WITH COMMON FEMORAL ARTERY (CFA) ACCESS, DURING A TRAUMA CASE, WHICH CONTRIBUTED TO ISCHEMIA OF THE LIMB REQUIRING A FASCIOTOMY. A PATIENT SUSTAINED A PELVIC FRACTURE DUE TO A FALL. THE PATIENT ARRIVED AT THE HOSPITAL WITH AN SBP OF 70 MMHG AND SIGNS OF HEMORRHAGIC SHOCK. A PELVIC BINDER WAS APPLIED TO THE PATIENT. THE DECISION WAS MADE TO USE A REBOA CATHETER. THE NEEDLE, FROM A PRYTIME REBOA CATHETER CONVENIENCE KIT, ENTERED THE CFA AT A 70° ANGLE RATHER THAN THE IDEAL 45° ANGLE, DUE TO MECHANICAL OBSTRUCTION OR INTERFERENCE FROM THE PELVIC BINDER. THE PHYSICIAN CONSIDERED THE ACCESS ANGLE AS THE PRIMARY FACTOR CONTRIBUTING TO THE LIMB ISCHEMIA WHICH RESULTED IN A FASCIOTOMY. ANOTHER POSSIBLE CONTRIBUTING FACTOR TO THE LIMB ISCHEMIA WAS THE 7FR INTRODUCER SHEATH BEING LEFT IN PLACE IN THE VESSEL, AFTER CATHETER WAS REMOVED, FOR ~2 HOURS. THE NEEDLE USED TO GAIN ACCESS TO THE CFA AND THE 7FR INTRODUCER SHEATH ARE MANUFACTURED AND LABELED BY OEMS AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THERE WAS NO REPORTED FAILURE OR DEFICIENCY WITH THE NEEDLE OR 7FR INTRODUCER SHEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2186688 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention