BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE

    MDR report key: 3092740 · Received May 3, 2013

    Report

    Report Number
    2024168-2013-02780
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 9, 2013
    Report Date
    April 9, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    DQX
    PMA / PMN Number
    K103101
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    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. CONCOMITANT PRODUCTS: GUIDE WIRE: RUNTHROUGH HP, WHISPER; STENT: XIENCE PRIME 2.25 X 23 MM. WHILE RE-POSITIONING THE BMW ELITE GUIDE WIRE AND THE WHISPER MS GUIDE WIRE, THE WHISPER MS WAS NOTED TO BE SEPARATED 13 CM FROM THE DISTAL END. THE DISTAL END WAS NOTED TO BE STICKING OUT OF THE AORTA. THE SEPARATED DISTAL PORTION OF THE WHISPER MS WAS RETRIEVED WITH A SNARE DEVICE WITHOUT DIFFICULTIES. NO ADVERSE PATIENT SEQUELA WAS REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. THE DEVICE IS NOT RETURNING. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION. THE WHISPER GUIDE WIRE REFERENCED IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). CORRECTION: MANUFACTURING SITE. IT IS INDICATED THAT THE DEVICE IS NOT RETURNING FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. 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 THE TARGET AREA WAS LOCATED IN THE POSTERIOR DESCENDING ARTERY (PDA) WITH MODERATE TORTUOSITY, HEAVY CALCIFICATION AND 90% STENOSIS. THERE WAS ALSO A TORTUOUS CALCIFIED AREA IN THE RIGHT CORONARY ARTERY (RCA). THE WHISPER MS GUIDE WIRE WAS ADVANCED TO THE POSTERIOR DESCENDING ARTERY AND A BALANCE MIDDLEWEIGHT (BMW) ELITE GUIDE WIRE WAS PLACED IN THE POSTERIOR LATERAL. THEN, A 2.25 X 15 MM NON-ABBOTT BALLOON WAS ADVANCED OVER THE WHISPER MS GUIDE WIRE, BUT THE BALLOON CATHETER DID NOT CROSS PAST THE MID RCA DUE TO THE ANATOMY. THUS, THE 2.25 X 15 MM NON-ABBOTT BALLOON WAS PULLED SLIGHTLY TO THE RCA AND THE BALLOON WAS DILATED IN THE RCA. AS AN INTRA-VASCULAR ULTRA SOUND (IVUS) CATHETER FAILED TO CROSS, THE RCA WAS FURTHER DILATED WITH THE 2.25 X 15 MM NON-ABBOTT BALLOON AND A 2.25 X 12 MM NON-ABBOTT BALLOON. THEN, AN ATTEMPT WAS MADE TO ADVANCE A 2.25 X 28 MM XIENCE PRIME STENT, HOWEVER IT FAILED TO CROSS. ANOTHER GUIDE WIRE (NON-ABBOTT) WAS DELIVERED TO HELP ADVANCE A STENT DELIVERY SYSTEM (SDS). THEN, WITH THREE GUIDE WIRES PLACED IN THE ANATOMY, A 2.25 X 23 MM XIENCE PRIME STENT WAS ADVANCED AND WAS POSITIONED AT THE LESION. THEN, THE BMW ELITE GUIDE WIRE AND THE NON-ABBOTT GUIDE WIRE WERE PULLED, BUT THE GUIDE WIRES COULD NOT BE RETRACTED, AS THEY FELT STUCK WITH THE LESION. THE 2.25 X 28 MM XIENCE PRIME STENT WAS RETRACTED FROM THE ANATOMY WITHOUT DEPLOYING THE STENT. AFTER THE NON-ABBOTT GUIDE WIRE WAS RETRACTED, THE WHISPER MS GUIDE WIRE AND THE BMW ELITE GUIDE WIRE WERE NOTED TO HAVE COME OUT OF POSITION IN THE LESIONS AND WERE LOCATED IN THE RCA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194246 HI-TORQUE BALANCE MIDDLEWEIGHT ELITE GUIDE WIRE GUIDE WIRE DQX AV-TEMECULA-CT 2110601

    Patients

    Seq Age Sex Outcome Treatment
    1