BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE WHISPER GUIDE WIRE

    MDR report key: 2232093 · Received September 1, 2011

    Report

    Report Number
    2024168-2011-06115
    Event Type
    Malfunction
    Date Received
    September 1, 2011
    Date of Event
    August 11, 2011
    Report Date
    August 11, 2011
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K013092
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. EVALUATION SUMMARY: EVALUATION OF THE RETURNED WHISPER GUIDE WIRE NOTED BLOOD ON THE GUIDE WIRE POLYMER COATING WHICH IS CONSISTENT WITH THE GUIDE WIRE BEING USED IN THE PATIENT AS REPORTED. THE GUIDE WIRE WAS RETURNED BACKLOADED THROUGH THE RETURNED BALLOON CATHETER. THERE WAS 26.9 CM OF THE DISTAL END OF THE GUIDE WIRE EXTENDING FROM THE DISTAL END OF THE BALLOON CATHETER. THERE WAS NO FOUND DAMAGE TO THE GUIDE WIRE. THE BALLOON CATHETER WAS RETURNED WITH BLOOD ON THE LOOSELY FOLDED BALLOON AND THERE WAS CONTRAST IN THE BALLOON. THE BALLOON CATHETER WAS RETURNED ADVANCED THROUGH A NON-ABBOTT GUIDING CATHETER. THE DISTAL END OF THE BALLOON WAS WRINKLED AT THE DISTAL END OF THE NON-ABBOTT GUIDING CATHETER. THERE WERE MULTIPLE BENDS IN THE HYPOTUBE DISTAL TO THE STRAIN RELIEF TUBING FOR A LENGTH OF 86 CM. A NON-ABBOTT ROTATING HEMOSTATIC VALVE (RHV) AND STOPCOCK WERE RETURNED. THE TIP OF THE NON-ABBOTT GUIDING CATHETER WAS PROLAPSED. FACTORS THAT MAY CONTRIBUTE TO THE INABILITY TO RETRACT THE CATHETER OVER THE GUIDE WIRE AND CAUSE RESISTANCE BETWEEN THE DEVICES MAY INCLUDE, BUT NOT LIMITED TO, DEVICE PLACEMENT TECHNIQUE, GUIDING CATHETER SUPPORT, INNER DIAMETER OF GUIDE WIRE LUMEN, OUTER DIAMETER OF THE GUIDE WIRE, CONDITION OF THE GUIDE WIRE, BUILD UP OF BLOOD OR CONTRAST, OR DAMAGE TO THE CATHETER. THE OUTER DIAMETER OF THE DISTAL TIP OF THE GUIDE WIRE WAS MEASURED WITH A HOLE GAUGE AND THIS MET MANUFACTURING CRITERIA. THE OUTER DIAMETER OF THE CORE WAS MEASURED WITH A LASER MICROMETER AND THIS MET MANUFACTURING CRITERIA. THE INNER DIAMETER OF THE GUIDE WIRE LUMEN OF THE BALLOON CATHETER WAS MEASURED AND MET MANUFACTURING CRITERIA. THE BALLOON CATHETER COULD NOT BE REMOVED FROM THE GUIDING CATHETER. THERE WAS RESISTANCE AT THE WRINKLED PORTION OF THE BALLOON. AFTER THE BALLOON WAS INFLATED AND THEN DEFLATED, THE BALLOON CATHETER WAS REMOVED FROM THE NON-ABBOTT GUIDING CATHETER. THE RETURNED GUIDE WIRE WAS ADVANCED THROUGH THE BALLOON CATHETER AND REMOVED WITH NO RESISTANCE NOTED. AFTER THE RETURNED GUIDE WIRE WAS BACKLOADED THROUGH THE BALLOON CATHETER, THE BALLOON WAS INFLATED TO RATED BURST PRESSURE (RBP) AND THE CATHETER WAS CHECKED FOR GUIDE WIRE COLLAPSE REVERSIBILITY. ANALYSIS COULD NOT CONFIRM THE REPORTED RESISTANCE AS THE GUIDE WIRE WAS NOT FROZEN IN THE GUIDE WIRE LUMEN WHILE THE BALLOON WAS PRESSURIZED. THE GUIDE WIRE WAS REMOVED WITH NO RESISTANCE NOTED AFTER THE INDEFLATOR WAS IN THE NEUTRAL POSITION. THE LOT HISTORY RECORD REVIEW AND SIMILAR INCIDENT QUERY FOR THIS PRODUCT WAS NOT PERFORMED BECAUSE THE PART AND/OR LOT NUMBER WAS NOT REPORTED AND NO PRODUCT IDENTIFICATION WAS AVAILABLE ON THE RETURNED PRODUCT. MANUFACTURING PERFORMS A 100% VISUAL INSPECTION OF THE GUIDE WIRE TIPS AFTER THEY ARE LOADED INTO THE DISPENSER AND PERFORMS AN OUTER DIAMETER INSPECTION OF ALL DEVICES PRIOR TO PACKAGING. ADDITIONALLY, QUALITY CONTROL PERFORMS ON LINE RELIABILITY TESTING TO VERIFY PRODUCT QUALITY.

    Description of Event or Problem · 1

    REPORTEDLY THE NC TREK BALLOON CATHETER WAS USED FOR POST DILATATION OF A VISION STENT (4.0X23) TO TREAT A LESION LOCATED IN THE RIGHT CORONARY ARTERY WITH MILD TORTUOSITY AND MILD CALCIFICATION. AFTER USE OF THE NC TREK BALLOON CATHETER AT 22 ATM FOR POST DILATATION, THE BALLOON CATHETER BECAME STUCK ON AN UNKNOWN WHISPER GUIDE WIRE SO EVERYTHING WAS WITHDRAWN AS ONE UNIT. REPORTEDLY THE BALLOON WAS FULLY DEFLATED DURING ATTEMPTS TO WITHDRAW THE CATHETER AND THERE WAS NO RESISTANCE FELT BETWEEN THE VISION STENT AND THE BALLOON CATHETER. THE ONLY RESISTANCE FELT WAS WITH THE WHISPER GUIDE WIRE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE PATIENT EFFECTS. A CLINICALLY SIGNIFICANT DELAY IN PROCEDURE WAS NOT REPORTED. NO ADDITIONAL EVENT OR PATIENT INFORMATION WAS PROVIDED.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR DILATATION CATHETER: NC TREK (4.0X20 MM)