BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 898680 · Received August 17, 2007

    Report

    Report Number
    2024168-2007-00328
    Event Type
    Injury
    Date Received
    August 17, 2007
    Date of Event
    July 17, 2007
    Report Date
    July 17, 2007
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K991152
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION - PRODUCT PERFORMANCE ENGINEERING REVIEWED THE INCIDENT INFORMATION. GUIDE WIRE TIP DAMAGE OF THIS NATURE MAY HAPPEN WHEN THE CORE IS SUBJECTED TO TENSILE OR TORSIONAL LOADS BEYOND ITS DESIGN LIMITS. 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 OR 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. IN THIS CASE, THE GUIDE WIRE APPEARED TO BE TRAPPED BEHIND A STENT THAT WAS DEPLOYED AT A BIFURCATION. THE GUIDE WIRE APPARENTLY SEPARATED IN THE ATTEMPT TO REMOVE THE TRAPPED GUIDE WIRE.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION REQUIRING SURGICAL INTERVENTION. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT DURING DEPLOYMENT OF ANOTHER COMPANY'S STENT IN THE LAD, THE BMW GUIDE WIRE BECAME STUCK BETWEEN THE STENT AND THE VESSEL WALL. DURING AN ATTEMPT TO REMOVE THE GUIDE WIRE, THE DISTAL TIP SEPARATED. THE PT WAS SENT TO SURGERY TO REMOVE THE SEPARATED PORTION OF THE GUIDE WIRE. NO ADDITIONAL EVENT OR PT INFORMATION IS AVAILABLE.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Hospitalization| R STENT: TAXUS 3.5X24