BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2160570 · Received July 13, 2011

    Report

    Report Number
    3003775027-2011-00026
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 15, 2011
    Report Date
    June 17, 2011
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K031277
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE ANALYSIS WAS PERFORMED BY (B)(4) INVESTIGATION OF THE GUIDE WIRE COULD NOT BE CONDUCTED BECAUSE IT WAS NOT RETURNED. INVESTIGATION OF THE PRODUCTION RECORD REVEALED NO ANOMALY. BASED ON THE PROVIDED INFORMATION, IT COULD NOT BE DETERMINED OR IDENTIFIED IF THERE WAS ANY PRODUCT ISSUE, INCLUDING COIL STRETCH AND/OR GUIDE WIRE SEPARATION. DURING THE PRODUCTION PROCESS, ALL PRODUCTS ARE INSPECTED FOR INTACTNESS AND BEING FREE OF DEFECT AT THE TIME OF PACKAGING TO HOLDER TUBE AND STERILE POUCH, AND THE INSPECTION-PASSED PRODUCT AT THE TIME OF WITHDRAWAL FROM THE HOLDER TUBE.

    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 EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TIP OF THE GUIDE WIRE WAS FOUND TO BE FRACTURED WHEN IT WAS REMOVED FROM THE HOOP. THE SECOND GUIDE WIRE, FROM THE SAME LOT, COULD NOT BE REMOVED FROM THE HOOP. NEITHER GUIDE WIRE WAS USED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 100430A411

    Patients

    Seq Age Sex Outcome Treatment
    1