BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALT BALLAST INTRODUCER SHEATH

    MDR report key: 24489721 · Received March 2, 2026

    Report

    Report Number
    MW5184591
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    February 24, 2026
    Report Date
    February 24, 2026
    Manufacturer
    BALT USA , LLC
    Product Code
    DQY
    Adverse Event
    Yes
    Report Source
    Voluntary report
    Reporter Location
    GA, US
    Reporter Occupation
    003
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    DURING A STROKE CASE WHEN A APRO SWIFT CATHETER WAS BEING EXTRACTED FROM THE INTRODUCER SHEATH IT STARTED TO UNRAVEL AND HAD PLASTIC COMING WITH IT. THE EVENTS LEADING UP TO THE PROCEDURE INCIDENT WERE AS FOLLOWS: 1 BALT BALLAST INTRODUCER SHEATH WAS INTRODUCED INTO THE RIGHT ICA. LOT F251200867 REF (B)(4) MEDTRONIC APRO 70 SWIFT CATHETER 132CM WAS INTRODUCED THROUGH THE GUIDE SHEATH. LOT JL25-007 REF (B)(4) MEDTRONIC SOLITAIRE 4X40 WAS INTRODUCED INTO THE SHEATH. LOT D002067 REF (B)(4) UPON REMOVAL, THE APRO STARTED TO 'UNRAVEL' AND BITS OF PLASTIC CAME WITH IT AND THEY STOPPED. 5 THE SOLITAIRE WAS UNABLE TO BE RETRIEVED 6 THE INTRODUCER SHEATH WITH ALL ITEMS HAD TO BE REMOVED TOGETHER, WHICH ISN'T IDEAL. UPON REMOVAL OF THE ITEMS IN ONE UNIT IT WAS NOTICED THE APRO WAS FRAYED. THE PATIENT SUFFERED DAMAGE FROM THE FRAYED APRO AND IS IN CRITICAL CONDITION AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    52085 BALT BALLAST INTRODUCER SHEATH CATHETER, PERCUTANEOUS DQY BALT USA , LLC F251200867

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Life Threatening