BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATERFLEX PTCA GUIDE WIRE

    MDR report key: 3654193 · Received March 3, 2014

    Report

    Report Number
    3003775027-2014-00017
    Event Type
    Injury
    Date Received
    March 3, 2014
    Date of Event
    February 4, 2014
    Report Date
    February 5, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K043422
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: INVESTIGATION OF THE RETURNED PROWATERFLEX GUIDE WIRE REVEALED THAT THE COIL OF THE GUIDE WIRE WAS STRETCHED AT THE MIDDLE BRAZING TOWARD THE DISTAL DIRECTION, AND WAS SEPARATED AT APPROXIMATELY 25MM LENGTH. CORE WIRE WAS FOUND SEPARATED AT 3 MM FROM DISTAL END OF THE GUIDE WIRE. THE DISTAL PORTION REPORTEDLY SEPARATED DURING PACKING OF THE DEVICE FOR RETURN AND WAS NOT RETURNED. OBSERVATION OF THE BROKEN SITES BY SCANNING ELECTRON MICROSCOPE REVEALED THE CORE WIRE BREAKAGE, DUE TO REPEATED BENDS AND COIL SEPARATION BY PULLING FORCE. WITH THE PROVIDED INFORMATION, THE RELATIONSHIP BETWEEN THE GUIDE WIRE AND THE VESSEL DISSECTION COULD NOT BE DETERMINED. WITH THE INFORMATION THAT THE GUIDE WIRE BECAME SEVERELY STRETCHED DURING THE ATTEMPT TO RETRACT IT, IT IS POSSIBLE THAT THE CORE OF THE PROWATERFLEX COULD HAVE SEPARATED IN THE ANATOMY, HOWEVER THIS COULD NOT BE DETERMINED. THE BREAKAGE OF THE CORE WIRE IS DEEMED TO BE DUE TO THE REPEATED BENDING FORCE WHICH MIGHT HAVE BEEN GIVEN TO THE GUIDE WIRE, AND OCCURRED WHEN THE ACCUMULATED BENDING FORCE REACHED AND EXCEEDED THE PRODUCT DESIGN LIMIT. THE INSTRUCTIONS FOR USE (IFU) OF THE PROWATERFLEX GUIDE WIRE DESCRIBES IN ITS WARNING SECTION: 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, RESULTING IN FRAGMENTS BEING LEFT INSIDE THE VESSEL, AND SEPARATION OR BREAKAGE OF GUIDE WIRE AND CORONARY ARTERY DISSECTION AS ONES OF POSSIBLE COMPLICATIONS AND ADVERSE EVENTS.

    Additional Manufacturer Narrative · 1

    (B)(4):DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION.THE DEVICE WAS RECEIVED. THE INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL AVAILABLE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TARGET LESION WAS LOCATED IN THE PROXIMAL TO MID LEFT ANTERIOR DESCENDING ARTERY (LAD) WITH NO TORTUOSITY AND NO CALCIFICATION. A PROWATER FLEX GUIDE WIRE WAS ADVANCED AND A NON-ABBOTT STENT WAS IMPLANTED. THE STENT WAS THOUGHT TO BE WELL APPOSED; HOWEVER THIS WAS NOT CONFIRMED VIA INTRA VASCULAR ULTRASOUND (IVUS). NO POST-DILATATION WAS PERFORMED. DURING RETRACTION OF THE PROWATER FLEX GUIDE WIRE, RESISTANCE WAS ENCOUNTERED. THE GUIDE WIRE WAS NOT JAILED BEHIND THE STENT, BUT SEEMED TO BE CAUGHT ON A STENT STRUT. DURING THE ATTEMPT TO RETRACT THE GUIDE WIRE, IT BECAME SEVERELY STRETCHED, BUT IT WAS CONFIRMED THAT IT WAS NOT SEPARATED. AS THE GUIDE WIRE COULD NOT BE REMOVED, AN UNSPECIFIED 1.5 MM BALLOON WAS USED TO HELP RELEASE IT. THE GUIDE WIRE WAS THEN ABLE TO BE PULLED BACK; HOWEVER DURING RETRACTION, A DISSECTION OCCURRED IN THE PROXIMAL LAD. ANOTHER NON-ABBOTT STENT WAS IMPLANTED TO COVER THE DISSECTION. NO ADVERSE PATIENT SEQUELA WAS REPORTED. AFTER THE PROCEDURE, DURING PACKING OF THE DEVICE FOR RETURN, THE GUIDE WIRE BECAME SEPARATED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    127568 ASAHI PROWATERFLEX PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 130205A521

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention STENT: BOSTON SCIENTIFIC PROMUS PREMIER