BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE IRON MAN GUIDE WIRE

    MDR report key: 1151435 · Received September 5, 2008

    Report

    Report Number
    2024168-2008-00778
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 7, 2008
    Report Date
    August 8, 2008
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K984394
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY - SURGICAL INTERVENTION, PERMANENT IMPAIRMENT. REPORTING RATIONALE: A PORTION OF THE GUIDEWIRE REMAINS IN THE PT AND CABG WAS PERFORMED. DEVICE ISSUE: DIFFICULT TO REMOVE. IT WAS REPORTED THAT AFTER IMPLANTING A STENT IN THE MID LAD, ANOTHER CO'S STENT WAS DEPLOYED IN THE PROXIMAL LAD. AT THIS TIME A PERFORATION WAS OBSERVED. A GUIDE WIRE CHANGE WAS GOING TO BE MADE FOR TREATMENT OF THE PERFORATION, BUT WHILE ATTEMPTING TO REMOVE THE IRON MAN GUIDE WIRE, IT WAS STUCK WITH THE IMPLANTED STENT. AFTER CONTINUING TO PULL ON THE GUIDE WIRE, THE IMPLANTED STENT BEGAN TO MOVE BACK INTO THE LEFT MAIN. THE PROCEDURE WAS ABORTED AND THE PT WAS TAKEN TO SURGERY. ON THE WAY TO THE OR, THE PT EXPERIENCED V-FIB AND WENT INTO CARDIAC ARREST. IT WAS FURTHER REPORTED THAT THE PT EXPERIENCED AN MI. MOST OF THE GUIDE WIRE WAS REMOVED DURING SURGERY, HOWEVER, A PIECE OF THE GUIDE WIRE COULD NOT BE REMOVED AND REMAINS IN THE PT. THE PT ALSO HAD A BYPASS TO THE LAD AND REPORTEDLY NOT DOING WELL. FURTHER INFO WAS REPORTED THAT PRIOR TO USE, A BUMP WAS OBSERVED ON THE GUIDE WIRE SOLDER JOINT, BUT IT WAS NOT FELT THAT IT WOULD BE A PROBLEM. NO ADD'L EVENT OR PT INFO IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACS HI-TORQUE IRON MAN GUIDE WIRE 74DQX DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 7070291

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| L| R| S STENT: ENDEAVOR| GUIDE WIRE: WIGGLE