BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 20211833 · Received September 13, 2024

    Report

    Report Number
    3026788751-2024-00012
    Event Type
    Injury
    Date Received
    September 13, 2024
    Date of Event
    August 22, 2024
    Report Date
    September 13, 2024
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    OFC
    UDI-DI
    00863092000101
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, 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, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF A THROMBUS REQUIRING A THROMBECTOMY FOR TREATMENT. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY THE OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. ON (B)(6) 2024 PRYTIME WAS INFORMED OF THE FOLLOWING CASE. A FEMALE PATIENT INVOLVED IN A MOTOR VEHICLE COLLISION ARRIVED AT THE FACILITY HYPOTENSIVE. CT IMAGING IDENTIFIED BLEEDING FROM THE LIVER AND COLON. THE PATIENT WAS TAKEN TO THE OR, WHERE AN EX-LAP WAS PERFORMED. A 7 FR INTRODUCER SHEATH WAS PLACED IN THE COMMON FEMORAL ARTERY (CFA). A REBOA CATHETER WAS PLACED THROUGH THE INTRODUCER SHEATH AND INFLATED. THE LIVER AND COLON WERE REPAIRED BUT THERE CONTINUED TO BE HIGH LEVELS OF ARTERIAL BLEEDING WITHOUT A GOOD SOURCE. THE PORTAL VEIN BRANCHES WERE LIGATED. AFTER THE BLEEDING WAS STABLE, THE REBOA CATHETER WAS DEFLATED AND REMOVED. THE INTRODUCER SHEATH REMAINED IN PLACE IN THE PATIENT. AT THIS POINT, THE PATIENT HAD A GOOD BLOOD PRESSURE (BP) DISTAL TO THE INTRODUCER SHEATH. THE PATIENT STARTED BLEEDING AGAIN IN THE ICU. DUE TO THE ONGOING HEMODYNAMIC INSTABILITY, A SECOND REBOA CATHETER WAS INSERTED THROUGH THE EXISTING INTRODUCER SHEATH AND INFLATED. AN ADRENAL ARTERY LACERATION WAS FOUND THAT HAD NOT BEEN IDENTIFIED INITIALLY. THE LEFT ADRENAL ARTERY WAS LIGATED. THE SECOND REBOA CATHETER WAS EVENTUALLY REMOVED IN THE OR. THE INTRODUCER SHEATH WAS REMOVED LATER THAT NIGHT. THERE WERE LEFT LOWER EXTREMITY (LLE) PULSE DISCREPANCY ISSUES OVERNIGHT. THE FOLLOWING MORNING IT WAS REPORTED THAT NO DISTAL LLE PULSES WERE PALPABLE. AN ARTERIAL DUPLEX WAS PERFORMED WHICH IDENTIFIED AN ILIAC ARTERY THROMBUS. A THROMBECTOMY WAS PERFORMED. AT THE TIME THIS INFORMATION WAS OBTAINED, THE PATIENT'S LLE FLOW HAD BEEN RE-ESTABLISHED, AND THE PATIENT REMAINS ALIVE. PER THE PHYSICIAN, THE PATIENT'S VASCULAR ANATOMY WAS INCREDIBLY SMALL ON IMAGING. THE INTRODUCER SHEATH WAS NEARLY OCCLUSIVE OF THE PATIENT'S CFA FOR A TOTAL OF 12 HOURS 51 MINUTES, WHICH MAY HAVE CONTRIBUTED TO THE DEVELOPMENT OF THE THROMBUS. THERE WAS NO REPORTED OR ALLEGED FAILURE OF THE INTRODUCER SHEATH OR ITS LABELING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1112801 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES, INC. 00863092000101

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention