BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER MS GUIDE WIRE

    MDR report key: 3171005 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03743
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 17, 2013
    Report Date
    May 21, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K101116
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ADDITIONAL HI-TORQUE WHISPER GUIDE WIRE MENTIONED IS BEING FILED UNDER A SEPARATE MANUFACTURER REPORT NUMBER. CONCOMITANT PRODUCTS: DILATATION CATHETER: 2.0X30MM MAVERICK; GUIDE CATHETER: 6F (UNSPECIFIED). THE GUIDE WIRE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE RESISTANCE WITH THE BALLOON CATHETER, AND BUNCHED AND TORN POLYMER WERE ABLE TO BE CONFIRMED. BASED ON A VISUAL, DIMENSIONAL, AND FUNCTIONAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE RESULTS OF THE QUERY OF SIMILAR INCIDENTS IN THE COMPLAINT HANDLING DATABASE FOR THIS LOT DID NOT INDICATE A MANUFACTURING ISSUE. BASED ON THE REVIEWED INFORMATION, NO PRODUCT DEFICIENCY WAS IDENTIFIED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE TO TREAT A LESION IN AN UNSPECIFIED CORONARY ARTERY, WHEN ADVANCING A 2.0X30 NON-ABBOTT BALLOON DILATATION CATHETER (BDC) OVER A 014 WHISPER MS GUIDE WIRE, THE BDC BECAME STUCK AT THE DISTAL END OF THE GUIDE WIRE, APPROXIMATELY 10 CENTIMETERS FROM THE DISTAL END OF THE WHISPER MS. THE BDC AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. AN ATTEMPT WAS MADE TO ADVANCE THE SAME BDC OVER A NEW 014 WHISPER MS GUIDE WIRE AND THE BDC BECAME STUCK AGAIN IN THE SAME AREA OF THE GUIDE WIRE AND THE BDC AND THE GUIDE WIRE WERE REMOVED AS A SINGLE UNIT. AFTER BOTH GUIDE WIRES WERE REMOVED FROM THE ANATOMY THE PHYSICIAN MANAGED TO REMOVE THE BDC FROM THE WIRE. THE POLYMER COATING ON THE GUIDE WIRES LOOKED SCRATCHED AND FELT ROUGH, BUT NO POLYMER COATING WAS PEELED NOR MISSING FROM THE GUIDE WIRES. THE PROCEDURE WAS COMPLETED WITHOUT ISSUE USING A NEW UNSPECIFIED GUIDE WIRE WITH THE SAME BDC. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO OCCURRENCE OF A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL FILED MEDWATCH REPORT, THE ABBOTT VASCULAR RETURNED GOODS LAB RECEIVED A WHISPER MS GUIDE WIRE WITH THE PROXIMAL END OF ITS POLYMER COATING BUNCHED AND TORN. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE SITE WAS AWARE OF THE BUNCHED AND TORN MATERIAL AND THAT THE REPORTED SCRATCHED AND ROUGH POLYMER COATING WERE INTENDED TO DESCRIBE THE OBSERVED BUNCHED AND TORN POLYMER COATING. REPORTEDLY, THE BUNCHING AND TEARING MUST HAVE OCCURRED IN THE PATIENT'S ANATOMY, AS THE NON-ABBOTT BALLOON CATHETER HAD ONLY FELT RESISTANCE ON THE DISTAL 10 CENTIMETERS OF THE DEVICE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271205 HI-TORQUE WHISPER MS GUIDE WIRE GUIDE WIRES DQX AV-TEMECULA-CT 3030271

    Patients

    Seq Age Sex Outcome Treatment
    1