BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BALLAST 088 LONG SHEATH

    MDR report key: 12697047 · Received October 26, 2021

    Report

    Report Number
    12697047
    Event Type
    Malfunction
    Date Received
    October 26, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 12, 2021
    Manufacturer
    BALT USA LLC
    Product Code
    DQY
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    AZ
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 0

    THE BALLAST¿ 088 LONG SHEATH IS A SINGLE LUMEN, BRAID-REINFORCED, VARIABLE STIFFNESS CATHETER COULD NOT BE REMOVED FROM PATIENT. PER THE CHART, THE PROCEDURE WAS COMPLICATED BY SEVERE VASOSPASM AND RIGHT RADIAL CATHETER WAS LEFT IN PLACE. PER THE OPERATIVE (OP) NOTES, THE BALLAST¿ 088 LONG SHEATH CATHETER WAS THEN REMOVED AND EXCHANGED FOR AN 8-FRENCH ANGIO-SEAL DEVICE, WHICH WAS DEPLOYED WITHOUT COMPLICATION ACHIEVING EXCELLENT HEMOSTASIS. ATTEMPTS TO REMOVE THE BALLAST CATHETER FROM THE RIGHT RADIAL ARTERY WERE UNSUCCESSFUL AND THEREFORE, VASCULAR SURGERY WAS CONSULTED FOR REMOVAL OF THIS CATHETER. THE PATIENT WAS THEN TRANSFERRED TO INTENSIVE CARE UNIT IN STABLE CONDITION HAVING TOLERATED THE PROCEDURE WELL. ANOTHER PROCEDURE WAS DONE FOR THE REMOVAL OF RIGHT RADIAL ARTERIAL SHEATH. ACCORDING TO THE OP FINDINGS, SHREDDED INTRA-ARTERIAL CATHETER WITHIN THE RIGHT RADIAL ARTERY THAT IS FOUND TO HAVE A HIGH ORIGIN NEAR THE AXILLA CONSISTENT WITH A BRACHIORADIAL ARTERY. DAMAGED PROXIMAL BRACHIAL ARTERY WITH SIGNIFICANT INTIMAL IRREGULARITY REQUIRING AN AXILLOBRACHIAL BYPASS. LARGE THROMBUS EVACUATED FROM THE RIGHT SUBCLAVIAN/AXILLARY ARTERY. HOWEVER, PER THE OP NOTES, THERE WERE NO COMPLICATION RELATED TO THE REMOVAL.

    Description of Event or Problem · 1

    THE BALLAST¿ 088 LONG SHEATH IS A SINGLE LUMEN, BRAID-REINFORCED, VARIABLE STIFFNESS CATHETER COULD NOT BE REMOVED FROM PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1594386 BALLAST 088 LONG SHEATH CATHETER, PERCUTANEOUS DQY BALT USA LLC BALLAST90 F21050006

    Patients

    Seq Age Sex Outcome Treatment
    1 18980 DA Other