BEUDAMED
    FDA Adverse Event Injury Summary report: N

    REBOA CATHETER CONVENIENCE KIT

    MDR report key: 16570353 · Received March 18, 2023

    Report

    Report Number
    3014034613-2023-00003
    Event Type
    Injury
    Date Received
    March 18, 2023
    Date of Event
    February 13, 2023
    Report Date
    March 18, 2023
    Manufacturer
    PRYTIME MEDICAL DEVICES, INC.
    Product Code
    OFC
    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 IN AN ABUNDANCE OF CAUTION DUE TO THE PRESENCE OF AN INTRODUCER SHEATH, WHICH MAY HAVE CONTRIBUTED TO A THROMBUS FORMATION REQUIRING A THROMBECTOMY. THE INTRODUCER SHEATH IS MANUFACTURED AND LABELED BY OEM AND INCLUDED IN PRYTIME'S CONVENIENCE KIT. THERE WAS NO REPORTED OR ALLEGED FAILURE OF THE KIT COMPONENTS, THE KIT, OR LABELING. A 400-500LB PATIENT WAS HIT BY A CAR WHILE STANDING ON THE SIDE OF THE ROAD. THE PATIENT RECEIVED ONGOING CPR FOR 20 MINUTES AND ROSC WAS ACHIEVED. THE PATIENT WAS HYPOTENSIVE AND RECEIVED 2 UNITS OF BLOOD. AN XRAY WAS PERFORMED AND REVEALED AN OPEN BOOK PELVIS; A PELVIC BINDER WAS PLACED. AN INTRODUCER SHEATH WAS PLACED IN THE PROFUNDA, NOT THE CFA. THE INTRODUCER SHEATH WAS REMOVED AFTER APPROXIMATELY 8 HOURS. POST SHEATH REMOVAL, A THROMBUS WAS IDENTIFIED DISTAL TO THE INTRODUCER SHEATH SITE REQUIRING A THROMBECTOMY. THE PRESENCE OF THE INTRODUCER SHEATH WITHIN THE SMALL ARTERY (PROFUNDA) FOR AT LEAST 8 HOURS COULD NOT BE RULED OUT AS A POTENTIAL CONTRIBUTOR IN THE THROMBUS FORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    998625 REBOA CATHETER CONVENIENCE KIT Catheter introducer kit OFC PRYTIME MEDICAL DEVICES, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention