BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATERFLEX PTCA GUIDE WIRE

    MDR report key: 3092392 · Received May 3, 2013

    Report

    Report Number
    3003775027-2013-00018
    Event Type
    Malfunction
    Date Received
    May 3, 2013
    Date of Event
    April 5, 2013
    Report Date
    April 8, 2013
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K032615
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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. THE XIENCE XPEDITION DEVICE REFERENCED, IS BEING FILED UNDER A SEPARATE MEDWATCH REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: EVALUATION SUMMARY: NO NOTABLE IRREGULARITY WAS OBSERVED WITH THE RETURNED GUIDE WIRE, EXCEPT FOR SLIGHT BENDS SUPPOSEDLY BECAUSE OF USE. THE RESISTANCE, REPORTEDLY FELT BETWEEN THE GUIDE WIRE AND THE STENT DELIVERY SYSTEM, IS SUPPOSED TO BE BECAUSE OF THE AFOREMENTIONED BENDS THAT MAY HAVE OCCURRED WITH THE GUIDE WIRE DURING USE, AND/OR OF SOME OTHER FACTOR THAT MIGHT OCCUR WITH THE DEVICE USED IN COMBINATION. DETAILS COULD NOT BE IDENTIFIED. THOUGH THE LOT HISTORY RECORD COULD NOT BE REVIEWED AS NO LOT INFORMATION WAS AVAILABLE, BECAUSE ALL THE SHIPPED PRODUCTS ARE INSPECTED FOR MEETING THE RELEASE ACCEPTANCE CRITERIA, IT IS INFERRED THAT THE GUIDE WIRE OF THIS SUBJECT WAS ALSO FREE FROM DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A CORONARY ARTERY INTERVENTION, AN ASAHI PROWATER FLEX WIRE WAS USED WITH MULTIPLE DEVICES. AFTER PREDILATATION OF THE MODERATELY TORTUOUS, HEAVILY CALCIFIED LEFT CIRCUMFLEX LESION, THE 2.25X8MM XIENCE XPEDITION STENT DELIVERY SYSTEM (SDS) WAS ADVANCED OVER THE WIRE AND DEPLOYED AT 14 ATMOSPHERES (ATM) WITHOUT ISSUE. NEGATIVE PRESSURE WAS PULLED, THEN THE DEVICE WAS ATTEMPTED TO BE REMOVED; HOWEVER, DURING REMOVAL OF THE SDS, POCKETS OF RESISTANCE WERE ENCOUNTERED, SO THE SDS AND WIRE WERE REMOVED AS ONE UNIT. THERE WAS NO ADVERSE PATIENT SEQUELA AND NO CLINICALLY SIGNIFICANT DELAY IN PROCEDURE REPORTED. THE LESION WAS REWIRED AND OPTICAL COHERENCE TOMOGRAPHY (OCT) WAS PERFORMED SHOWING EXCELLENT RESULTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195440 ASAHI PROWATERFLEX PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR STENT: 2.50X08MM XIENCE XPEDITION