BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI GRANDSLAM PTCA GUIDE WIRE

    MDR report key: 2216519 · Received August 18, 2011

    Report

    Report Number
    3003775027-2011-00031
    Event Type
    Malfunction
    Date Received
    August 18, 2011
    Date of Event
    July 11, 2011
    Report Date
    July 22, 2011
    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). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED ASAHI GUIDE WIRE NOTED THAT THE CORE WIRE WAS SEPARATED APPROXIMATELY 11 MM FROM THE TIP AND THE COIL WIRE WAS ELONGATED FROM THE MIDDLE BRAZING OVER THE CORE WIRE TOWARD THE DISTAL DIRECTION FOR APPROXIMATELY 13 CM BEFORE THE SEPARATION. THE SEPARATED DISTAL SECTION WAS NOT RETURNED. IN THIS CASE, THE TIP OF THE GUIDE WIRE MIGHT HAVE BEEN TRAPPED BY THE VERY CALCIFIED AND TORTUOUS ANATOMY AND ITS FREE MOVEMENT REPEATEDLY APPLIED AND BENDING AND PULL-APART FORCE MIGHT HAVE BEEN ACCUMULATED TO THE CORE WIRE, WITH THE COIL STRETCHING BY THE REMOVAL MANIPULATION TO THE GUIDE WIRE. SCANNING ELECTRON MICROSCOPY REVEALED DIMPLES, TRACE OF THE SEPARATION BY PULL-APART FORCE, ON THE BREAKAGE SITE. THE CORE WIRE MIGHT BE SEPARATED DUE TO THE ACCUMULATED FORCE WHICH FINALLY EXCEEDED THE PRODUCT DESIGN LIMIT, AND THE COIL WIRE MIGHT BE SEPARATED DUE TO PULL-APART AND TORSIONAL FORCE. IT IS REPORTED THAT THE GUIDE WIRE WAS IN ONE PIECE WHEN REMOVED FROM THE PATIENT; HOWEVER, IT COULD NOT BE DETERMINED WHEN THE GUIDE WIRE SEPARATED. THE ASAHI INSTRUCTIONS FOR USE (IFU) STATES: IF ANY RESISTANCE IS FELT DUE TO SPASM OR THE GUIDE WIRE BEING BENT OR TRAPPED WHILE OPERATING THE GUIDE WIRE IN THE BLOOD VESSEL OR REMOVING IT, DO NOT MOVE OR TORQUE THE GUIDE WIRE. STOP THE PROCEDURE. DETERMINE THE CAUSE OF RESISTANCE UNDER FLUOROSCOPY AND TAKE APPROPRIATE REMEDIAL ACTION. IF THE GUIDE WIRE IS MOVED EXCESSIVELY, IT MAY BREAK OR BECOME DAMAGED, WHICH MAY CAUSE BLOOD VESSEL INJURY OR RESULT IN FRAGMENTS BEING LEFT INSIDE THE VESSEL. A REVIEW OF THE LOT HISTORY RECORD DID NOT REVEAL ANY ANOMALIES ASSOCIATED WITH THIS PART AND LOT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND THERE WERE NO OTHER INCIDENTS REPORTED WITH THIS PART AND LOT COMBINATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO FILING THE INITIAL MEDWATCH THE FOLLOWING INFORMATION WAS RECEIVED: THE ASAHI GUIDE WIRE WAS USED SUCCESSFULLY IN THE CORONARY PROCEDURE. THE GUIDE WIRE BECAME DAMAGED DURING REMOVAL; HOWEVER, IT DID NOT SEPARATE INTO TWO PIECES. ALTHOUGH ANALYSIS OF THE RETURNED GUIDE WIRE REVEALED THE TIP OF THE WIRE WAS SEPARATED AND NOT RETURNED; IT WAS CONCLUDED THAT THIS OCCURRED DURING POST-PROCEDURAL HANDLING AND THAT NONE OF THE GUIDE WIRE REMAINS IN THE PATIENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DISTAL END OF THE GUIDE WIRE BECAME UNRAVELED DURING USE IN A VERY CALCIFIED AND TORTUOUS ANATOMY. NO INTERVENTION WAS REQUIRED AND THE DEVICE WAS REMOVED WITH NO ISSUES. ANOTHER SAME-SIZED ASAHI GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI GRANDSLAM PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 100518A021

    Patients

    Seq Age Sex Outcome Treatment
    1