BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ACS HI-TORQUE BALANCE MIDDLEWEIGHT GUIDE WIRE

    MDR report key: 1213506 · Received October 27, 2008

    Report

    Report Number
    2024168-2008-01016
    Event Type
    Injury
    Date Received
    October 27, 2008
    Date of Event
    September 25, 2008
    Report Date
    September 29, 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
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS AND CONCLUSION SUMMATION- PER THE JAPAN IFU, "DO NOT JAIL THE GUIDE WIRE BETWEEN THE STENT AND THE VESSEL WALL WHILE PLACING THE STENT IN A BIFURCATION AREA WHEN MULTIPLE GUIDE WIRES ARE USED. [IT MAY BECOME IMPOSSIBLE TO WITHDRAW THE GUIDE WIRE. IF STRONG FORCE IS APPLIED TO THE GUIDE WIRE, IT MAY RESULT IN DAMAGE OR SEPARATION.]" THE IFU ALSO WARNS, "NEVER PUSH, AUGER, WITHDRAW OR TORQUE A PRODUCT THAT MEETS RESISTANCE." AND FAILURE TO DO SO MAY RESULT IN; VESSEL TRAUMA, DAMAGE OR TIP SEPARATION, AND ALSO DAMAGE. IN CASE OF GUIDE WIRE SEPARATION IF IT REMAINS IN THE BODY, IT MAY NEED TO BE EXTRACTED WITH A SNARE DEVICE OR BY A MAJOR SURGICAL PROCEDURE." THE ROOT CAUSE IS LIKELY TO BE THE RESULT OF PROCEDURE CIRCUMSTANCES.

    Description of Event or Problem · 1

    REPORTING STATUS: SERIOUS INJURY/SURGICAL INTERVENTION. REPORTING RATIONALE: GUIDE WIRE SEPARATION REQUIRING SURGICAL INTERVENTION TO PREVENT PERMANENT IMPAIRMENT OR INJURY. DEVICE ISSUE: GUIDE WIRE SEPARATION. IT WAS REPORTED THAT BMW GUIDE WIRE WAS NOT ABLE TO BE REMOVED FROM THE PT'S ANATOMY, AS THERE WAS A STRONG RESISTANCE BETWEEN THE VESSEL WALL AND THE PREVIOUSLY DEPLOYED STENTS. THE GUIDE WIRE TIP SEPARATED WHEN AN ATTEMPT WAS MADE TO REMOVE THE TRAPPED GUIDE WIRE. SINCE, THE SEPARATED GUIDE WIRE WAS UNABLE TO BE REMOVED; THE PT WAS SENT TO SURGERY. THE SEPARATED PORTION OF THE GUIDE WIRE WAS SUCCESSFULLY REMOVED DURING SURGERY. NO ADDITIONAL 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 6102673

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Hospitalization| R OTHER: EXCELSIOR| DIL CATH: HIRYU| GUIDE WIRE: BALANCE HC| GUIDE CATH: AXCESS JR4.0 6F AL 0.75 SH 6F| STENT: TSUNAMI