BEUDAMED
    FDA Adverse Event Death Summary report: N

    CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER

    MDR report key: 14434597 · Received May 19, 2022

    Report

    Report Number
    2017865-2022-10398
    Event Type
    Death
    Date Received
    May 19, 2022
    Date of Event
    May 3, 2022
    Report Date
    August 22, 2022
    Manufacturer
    ABBOTT
    Product Code
    DQY
    UDI-DI
    05415067004222
    PMA / PMN Number
    K130257
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A DEVICE HISTORY RECORD (DHR) REVIEW WAS PERFORMED AND ALL REQUIRED MANUFACTURING PROCESSES AND INSPECTIONS STEPS WERE CONFIRMED TO BE COMPLETED PER THE REQUIREMENTS. THE DEVICE MET SPECIFICATIONS PRIOR TO LEAVING ABBOTT MANUFACTURING FACILITIES.

    Description of Event or Problem · 0

    RELATED MANUFACTURER REPORT NUMBER: 2017865-2022-10396, 2017865-2022-10397. DURING A DEVICE UPGRADE PROCEDURE, THE TENDRIL LEAD WAS ATTEMPTED TO BE IMPLANTED USING THE HISPRO CATHETER. AN ACCEPTABLE IMPLANT POSITION COULD NOT BE FOUND, SO A NEW APPROACH WAS ATTEMPTED WITH A CPS DIRECT UNIVERSAL CATHETER. LEAD PLACEMENT WAS AGAIN UNSUCCESSFUL, SO THE HISPRO CATHETER WAS AGAIN ATTEMPTED. AT THIS TIME, A DROP IN BLOOD PRESSURE OCCURRED WHICH WAS SUCCESSFULLY RESOLVED WITH MEDICATION. LEAD PLACEMENT WAS AGAIN ATTEMPTED BEFORE THE PHYSICIAN ELECTED TO ABORT THE IMPLANT PROCEDURE AND REMOVE THE HISPRO CATHETER. THE PATIENT'S BLOOD PRESSURE AGAIN DROPPED, HOWEVER, MEDICATION WAS UNSUCCESSFUL. CARDIOPULMONARY RESUSCITATION (CPR) WAS INITIATED AND MAINTAINED FOR 15 MINUTES. CHEST DRAINAGE WAS PERFORMED WHICH REVEALED BLEEDING AND A HEMOTHORAX. CPR WAS STOPPED AND THE PATIENT WAS PRONOUNCED DECEASED. THE PHYSICIAN SUSPECTED A PERFORATION OF THE SUPERIOR VENA CAVA OCCURRED EARLY IN THE PROCEDURE WHEN ACCESSING THE SUBCLAVIAN VEIN SYSTEM. THE PHYSICIAN DID NOT ALLEGE A MALFUNCTION ON ANY ABBOTT PRODUCT, NOR DID THEY ALLEGE ANY ABBOTT PRODUCT DIRECTLY CAUSED OR CONTRIBUTED TO THE PATIENT'S PASSING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    286642 CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER CATHETER, PERCUTANEOUS DQY ABBOTT DS2C023 7906526 05415067004222

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death