BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 3180732 · Received June 20, 2013

    Report

    Report Number
    3003775027-2013-00029
    Event Type
    Malfunction
    Date Received
    June 20, 2013
    Date of Event
    May 27, 2013
    Report Date
    May 28, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, 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. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC CO, LTD. INVESTIGATION OF RETURNED GRAND SLAM GUIDEWIRE REVEALED THE CORE WIRE WAS BROKEN APART APPROXIMATELY 13MM FROM THE DISTAL END. THE PROXIMAL SECTION WAS DEFORMED IN AN S SHAPE DOWN TO THE PROXIMAL END OF THE COIL SECTION. THIS CROOKED BEND WAS SUPPOSED TO BE DUE TO SOME ABRASIVE FORCE GIVEN TO THE GUIDE WIRE, BUT THE CIRCUMSTANCE AND THE TIMING OF OCCURRENCE COULD NOT BE IDENTIFIED. THE SEPARATED DISTAL PORTION WAS SHARPLY BENT IN A Z FORM AT THE SECTION NEXT TO THE BREAKAGE SITE, WHILE THE DISTAL END APPROXIMATELY 3MM WAS ROUNDLY BENT. THE SIZE OF THE Z DEFORMATION IS APPROXIMATELY 2MM IN EACH LENGTH, THE BEND WAS SO SHARP, IT WAS CONSEQUENTLY SUPPOSED THAT THE GUIDEWIRE WAS PULLED BACK IN Z SHAPE IN THE GUIDING CATHETER; HOWEVER, THIS COULD NOT BE DETERMINED. OBSERVATION BY SCANNING ELECTRON MICROSCOPE REVEALED A COUNTERCLOCKWISE TWIST AT THE BREAKAGE SITE OF THE PROXIMAL CORE WIRE, VERY LOCALLY, WHILE THE DIMPLE ON THE BREAKAGE FACE OF THE DISTAL CORE WIRE SUGGESTED THE BREAKAGE DUE TO THE PULL-APART FORCE. IT WAS COMPREHENSIVELY SUPPOSED THAT THE TWISTING AND PULLING FORCE WAS GIVEN TO THE SECTION LOCALLY, WHICH ENDED BY THE SEPARATION OF CORE WIRE. COIL WIRE WAS ELONGATED TO APPROXIMATELY 4-5 CM EACH SIDE RESPECTIVELY AND WAS BROKEN APART. THE WARNINGS SECTION OF THE INSTRUCTIONS FOR USE DESCRIBES: OBSERVE GUIDE WIRE MOVEMENT IN THE VESSELS. BEFORE A GUIDE WIRE IS MOVED OR TORQUED, THE TIP MOVEMENT SHOULD BE EXAMINED AND MONITORED UNDER FLUOROSCOPY. DO NOT MOVE OR TORQUE A GUIDE WIRE WITHOUT OBSERVING CORRESPONDING MOVEMENT OF THE TIP, OTHERWISE, THE GUIDE WIRE MAY BE DAMAGED AND / OR VESSEL TRAUMA MAY OCCUR. IF GUIDE WIRE TIP PROLAPSE IS OBSERVED, DO NOT ALLOW THE TIP TO REMAIN IN A PROLAPSED POSITION, OTHERWISE DAMAGE TO THE GUIDE WIRE MAY OCCUR. SEPARATION OR BREAKAGE OF GUIDE WIRE AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE RIGHT COMMON FEMORAL ARTERY WITH HEAVY CALCIFICATION. THE GRANDSLAM GUIDE WIRE WAS ADVANCED, BUT COULD NOT CROSS TO THE LESION DUE TO THE ANATOMY. DURING REMOVAL, THE GUIDE WIRE SEPARATED OUTSIDE THE ANATOMY. THERE WAS NO RESISTANCE NOTED DURING REMOVAL. A NEW WHISPER GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE SUCCESSFULLY. THE PATIENT HAD A GOOD OUTCOME. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    279961 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 121004A23S

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR