BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI CONFIANZA PRO PTCA GUIDE WIRE

    MDR report key: 1910086 · Received January 28, 2011

    Report

    Report Number
    3003775027-2010-00031
    Event Type
    Malfunction
    Date Received
    January 28, 2011
    Date of Event
    September 15, 2010
    Report Date
    October 12, 2010
    Manufacturer
    ABBOTT VASCULAR - CARDIAC THERAPIES
    Product Code
    DQX
    PMA / PMN Number
    K052339
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED. THE INVESTIGATION IS NOT YET COMPLETE.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: EVALUATION OF THE RETURNED CONFIANZA PRO 12 GUIDE WIRE REVEALED THAT THERE WAS A CORE SEPARATION AT THE PROXIMAL SIDE OF THE MIDDLE BRAZING, THAT COIL WAS STRETCHED OVER THE CORE WIRE AND THEN EXTREMELY EXTENDED AND TANGLED. SCANNING ELECTRON MICROSCOPY (SEM) REVEALED THAT THE CORE WIRE AT THE BREAKAGE SITE WAS TWISTED COUNTERCLOCKWISE BEFORE FRACTURE. THOUGH THE TIP END BRAZING WAS FRACTURED, THE CORE WIRE COULD BE CONSIDERED NOT BROKEN FROM THE TRACE OF BRAZING OF CORE WIRE, MEANWHILE, THE COIL WAS FOUND BROKEN AT APPROXIMATELY 0.7 MM FROM TIP END. THE DEVICE INSTRUCTIONS FOR USE WARING SECTION 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." "WHEN TORQUING THE GUIDE WIRE, ROTATE IT CLOCKWISE AND COUNTERCLOCKWISE ALTERNATELY. DO NOT EXCEED TWO ROTATIONS (7200) IN THE SAME DIRECTION." AND, "SEPARATION OR BREAKAGE OF GUIDEWIRE" AS ONE OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS. IT IS PRESUMED THAT THE GUIDE WIRE DISTAL END WAS TRAPPED BY THE TOTALLY OCCLUDED LESION. COUNTERCLOCKWISE TORQUE MANIPULATION WAS CONSECUTIVELY APPLIED TO THE GUIDE WIRE, SO THAT THE CORE WIRE WAS SEPARATED DUE TO THE TWISTING FORCE EXCEEDING THE PRODUCT DESIGN LIMIT, THE COIL STRETCHED OVER THE CORE WIRE AND EXTREMELY EXTENDED WHEN THE GUIDEWIRE WAS PULLED BACK FOR REMOVAL, AND SEPARATED. A REVIEW OF THE LOT HISTORY RECORD FOR THIS DEVICE DID NOT PRODUCE ANY FINDINGS RELEVANT TO THIS REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN UNSPECIFIED PROCEDURE, THE CONFIANZA GUIDE WIRE WAS USED IN A TOTAL OCCLUSION AND WAS NOTED TO BE "FRAYED/UNRAVELED BACK TO THE JUNCTION-EXTREMELY STRETCHED OUT" AFTER REMOVAL FROM THE ANATOMY. A DIFFERENT GUIDE WIRE WAS USED TO COMPLETE THE PROCEDURE WITHOUT INCIDENT. NO PT EFFECT REPORTED. NO ADDITIONAL INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI CONFIANZA PRO PTCA GUIDE WIRE GUIDE WIRE DQX ABBOTT VASCULAR - CARDIAC THERAPIES NA 100122A081

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK GUIDE WIRE: UNSPECIFIED GUIDE WIRE