BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 1901994 · Received November 12, 2010

    Report

    Report Number
    2024168-2010-02436
    Event Type
    Injury
    Date Received
    November 12, 2010
    Date of Event
    October 21, 2010
    Report Date
    October 22, 2010
    Manufacturer
    ABBOTT VASCULAR-CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL SUMMARY: DIFFICULTY ADVANCING CAN BE AFFECTED BY NUMEROUS FACTORS INCLUDING, BUT NOT LIMITED TO, PT ANATOMICAL MORPHOLOGY, PT DISEASE STATE, PRE-DILATATION STRATEGY, DEVICE PLACEMENT TECHNIQUE, AND ACCESSORY DEVICE SUPPORT. IN THIS CASE, BASED ON THE CASE DESCRIPTION, IT APPEARS THAT THE DIFFICULTY ADVANCING IS DUE TO INTERACTION WITH THE PREVIOUSLY PLACED UNK STENT. IT WAS ALSO REPORTED THAT A NON-ABBOTT SUPPORT CATHETER WAS ADVANCED BUT ALSO MET RESISTANCE, FURTHER SUGGESTING THAT INTERACTION WITH THE UNK STENT CONTRIBUTED TO THE REPORTED DIFFICULTIES. DISSECTION IS LISTED IN THE PRODUCT INSTRUCTION FOR USE (IFU) AS A POTENTIAL PT EFFECT. THE IFU ALSO STATES: "DO NOT PUSH, AUGER, WITHDRAW OR TORQUE A GUIDE WIRE THAT MEETS RESISTANCE. FAILURE TO DO SO MAY RESULT IN VESSEL TRAUMA, GUIDE WIRE DAMAGE, GUIDE WIRE TIP SEPARATION, OR STENT DAMAGE." OVERALL, THE REPORTED DIFFICULTIES CROSSING AND DISSECTION APPEAR TO BE RELATED TO CASE CIRCUMSTANCES AND THERE IS NO INDICATION TO SUGGEST A PRODUCT RELATED DEFICIENCY. REVIEW OF THE DEVICE HISTORY RECORD FOR THIS LOT DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE INTERVENTIONAL PROCEDURE IN THE LEFT ANTERIOR DESCENDING (LAD) TARGET LESION, RESISTANCE WAS MET AND THE WHISPER WIRE COULD NOT ADVANCE THROUGH AN UNK STENT IMPLANTED IN THE LEFT MAIN DURING A PREVIOUS PROCEDURE. A NON-ABBOTT SUPPORT CATHETER WAS ADVANCED BUT THIS MET RESISTANCE ALSO. BOTH THE WHISPER AND SUPPORT CATHETER WERE REMOVED WITHOUT DIFFICULTY. A DISSECTION WAS THEN OBSERVED IN THE LAD. THE WHISPER AND SUPPORT CATHETER WERE READVANCED, CROSSING THE STENT, AND THE DISSECTION WAS TREATED WITH BALLOON ANGIOPLASTY AND IMPLANTATION OF A PROMUS 3.0 X 15 STENT. THERE WAS NO ADVERSE PT SEQUELA. THOUGH REQUESTED NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HI-TORQUE WHISPER MS GUIDE WIRE DQX ABBOTT VASCULAR-CARDIAC THERAPIES NA 0081601

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention OTHER: EV3 TRAILBLAZER SUPPORT CATHETER| UNK STENT