BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 5231829 · Received November 17, 2015

    Report

    Report Number
    3003775027-2015-00136
    Event Type
    Malfunction
    Date Received
    November 17, 2015
    Date of Event
    September 22, 2015
    Report Date
    October 13, 2016
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    ME, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: (B)(4). THE ANALYSIS WAS PERFORMED BY ASAHI INTECC. CO. LTD: WITH THE OUTCOMES OF INSPECTION OF THE RETURNED GUIDEWIRE, IT IS INFERRED THAT SOME SCRAPING FRICTION WAS CONTINUOUSLY GIVEN TO THE GUIDEWIRE SHAFT ON THE ONE SIDE OF THE SHAFT ONLY DURING THE REMOVAL OF THE GUIDEWIRE, RESULTING THE SCRAPING DAMAGE TO THE PTFE COATING. THE SCRAPING DAMAGE OF COATING SUCH AS OBSERVED WITH THIS RETURNED GUIDEWIRE ARE SEEN WHEN THE GUIDEWIRE SURFACE IS EXPOSED TO SOME EXCESSIVE SCRAPING OR SCRATCHING FORCE, AND IT IS HIGHLY SUPPOSED WITH THIS RETURNED PROWATER THAT THE EDGE OF SOME METALLIC INSERTER TOOL SUPPOSED TO BE USED WITH THE GUIDEWIRE WAS KEPT CONTACTED WITH THE GUIDEWIRE WITH ANGLE AND WITH FORCE DURING REMOVAL OF THE GUIDEWIRE. THIS COULD NOT BE IDENTIFIED HOWEVER FROM THE PROVIDED INFORMATION. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. WARNING SECTION OF INSTRUCTIONS FOR USE DESCRIBES: NEVER USE METALLIC NEEDLE OR METALLIC SHEATHS FOR INSERTION AND WITHDRAWAL OF GUIDEWIRE, OTHERWISE THE SURFACE OF GUIDEWIRE MAY BE DAMAGED SIGNIFICANTLY.

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, (B)(4) DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE DEVICE IS EXPECTED TO BE RETURNED TO ASAHI INTECC. CO. LTD FOR INVESTIGATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ASAHI PROWATER GUIDE WIRE WAS BEING USED DURING AN UN-SPECIFIED PROCEDURE. NO RESISTANCE WAS NOTED; HOWEVER, DURING USE, IT WAS NOTED THAT FOREIGN MATERIAL WAS COMING OFF OF THE GUIDE WIRE. IT WAS NOTED THAT THE GUIDE WIRE LOOKED FRAYED. THE DEVICE WAS REPLACED AND A NEW ASAHI PROWATER GUIDE WIRE WAS USED TO CONTINUE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS AND NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    759796 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 140526A331

    Patients

    Seq Age Sex Outcome Treatment
    1