BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ASAHI PROWATER PTCA GUIDE WIRE

    MDR report key: 2735909 · Received September 7, 2012

    Report

    Report Number
    3003775027-2012-00047
    Event Type
    Malfunction
    Date Received
    September 7, 2012
    Date of Event
    August 14, 2012
    Report Date
    August 14, 2012
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K022762
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, 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. EVALUATION SUMMARY: THE DEVICE IS MANUFACTURED BY ASAHI INTECC. CO. LTD. MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE DEVICE WAS RETURNED FOR EVALUATION. THE REPORTED EVENT WAS CONFIRMED. BASED ON VISUAL INSPECTION OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO NON-CONFORMANCES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT DEFICIENCY. IT SHOULD BE NOTED THAT THE WARNING SECTION OF THE INSTRUCTIONS FOR USE (IFU) STATES TO NEVER USE METALLIC NEEDLES OR A METALLIC SHEATH FOR INSERTION AND WITHDRAWAL OF GUIDEWIRE. OTHERWISE, THE SURFACE OF GUIDEWIRE MAY BE DAMAGED SIGNIFICANTLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A STANDARD WIRE INTRODUCER WAS USED WITH THE PROWATER GUIDEWIRE. THE PROWATER GUIDEWIRE WAS AT THE MODERATELY CALCIFIED TARGET LESION IN THE SECOND DIAGONAL ARTERY WHEN IT WAS DECIDED TO REMOVE THE GUIDEWIRE TO RESHAPE THE TIP. AFTER IT WAS WIPED DOWN WITH GAUZE OUTSIDE THE ANATOMY, THERE WERE TWO GREEN SPOTS NOTED ON THE GAUZE. THE PHYSICIAN THOUGHT THAT THE GREEN SPOTS MAY HAVE BEEN METAL COMING OFF THE GREEN SHAFT OF THE GUIDEWIRE. ANOTHER PROWATER GUIDEWIRE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT EFFECTS. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ASAHI PROWATER PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 101124A211

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR STANDARD WIRE INTRODUCER