BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1023244 · Received March 31, 2008

    Report

    Report Number
    2024168-2008-00240
    Event Type
    Injury
    Date Received
    March 31, 2008
    Date of Event
    March 5, 2008
    Report Date
    March 6, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013833
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFO. SIMILAR REPORTS ON RETURNED DEVICES TYPICALLY SHOWS THAT GUIDE WIRE TIP DAMAGE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS CAUSING THE DISTAL TIP TO DETACH. TYPICALLY, THE FRACTURE SITE MORPHOLOGY SHOWS THE CORE WAS EXPOSED TO FORCES CONSISTENT WITH THOSE APPLIED THROUGH PULLING, TORQUING, AND MANIPULATION. A GUIDE WIRE BEING OVER PULLED / OVER TORQUED WOULD REQUIRE THE TIP TO BE TRAPPED WITHIN THE ANATOMY OR ANOTHER DEVICE IN ORDER TO CREATE THE REQUIRED FORCES TO DAMAGE THE GUIDE WIRE. THE GUIDE WIRE USED IN THIS CASE WAS NOT RETURNED; THEREFORE, A DEFINITIVE ROOT CAUSE OF THE REPORTED ISSUE CANNOT BE DETERMINED.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - REQUIRED INTERVENTION/HOSPITALIZATION. REPORTING RATIONALE: GUIDE WIRE SEPARATION REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING PLACEMENT OF ANOTHER COMPANY'S STENT, RESISTANCE WAS MET WITH THE STENT. THE GUIDE WIRE SEPARATED IN THE PT. THE DEVICES WERE THEN REMOVED AS A UNIT; HOWEVER, AFTER REMOVAL IT APPEARED AS THOUGH SOME OF COILS WERE LEFT IN THE PT. THE PT WAS THEN SENT TO SURGERY FOR REMOVAL. ALL PORTIONS OF THE DEVICE WERE ABLE TO BE REMOVED AND THERE WAS NO PORTION LEFT IN THE PT. PT WAS DOING WELL POST SURGERY. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R