BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASAHI PROWATERFLEX PTCA GUIDE WIRE

    MDR report key: 4102726 · Received September 19, 2014

    Report

    Report Number
    3003775027-2014-00050
    Event Type
    Injury
    Date Received
    September 19, 2014
    Date of Event
    August 22, 2014
    Report Date
    August 25, 2014
    Manufacturer
    AV-ASAHI
    Product Code
    DQX
    PMA / PMN Number
    K032615
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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 IS MANUFACTURED BY (B)(6). MEDICAL DIVISION; HOWEVER, ABBOTT VASCULAR DISTRIBUTES THE DEVICE AND IS RESPONSIBLE FOR MDR REPORTING. THE DEVICE WAS NOT RETURNED; THEREFORE, A FAILURE ANALYSIS COULD NOT BE COMPLETED. THOUGH THE DEVICE INSPECTION COULD NOT BE DONE, IT IS PRESUMED WITH THE PROVIDED INFORMATION THAT THE GUIDE WIRE TIP END MIGHT HAVE BECOME CAUGHT IN THE VESSEL DUE TO AN UNIDENTIFIED CAUSE, WHERE REMOVAL MANIPULATION WITH FORCE AND/OR ROTATIONAL MANIPULATION MIGHT BE APPLIED, RESULTING IN THE BREAKAGE OF THE GUIDE WIRE DUE TO THE FORCE EXCEEDING THE PRODUCTS DESIGN LIMIT. ALL THE SHIPPED PRODUCTS ARE INSPECTED IN THE PRODUCTION PROCESS FOR MEETING PRODUCTS SPECIFICATIONS AND THE RELEASE CRITERIA. LOT HISTORY REVIEW REVEALED NO ANOMALY RELATING TO THE REPORTED EVENT. NO OTHER PRODUCT EXPERIENCE REPORT WAS RECEIVED FOR THIS LOT. THERE IS NO INDICATION OF A PRODUCT DEFICIENCY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PROCEDURE WAS TO TREAT A LESION IN THE CIRCUMFLEX (CX) ARTERY. UPON WITHDRAWAL OF THE PROWATER GUIDE WIRE, ALTHOUGH NO RESISTANCE WAS FELT, THE TIP OF THE GUIDE WIRE WAS NOTED TO BE SEPARATED. THE TIP OF THE GUIDE WIRE WAS SUCCESSFULLY RETRIEVED USING A SNARE DEVICE. INTRAVASCULAR ULTRASOUND (IVUS) WAS PERFORMED AND NO VESSEL INJURY WAS NOTED. THERE WAS A CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE, AND THE PATIENT WAS HOSPITALIZED OVERNIGHT FOR OBSERVATION. THERE WAS NO ADDITIONAL INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    584242 ASAHI PROWATERFLEX PTCA GUIDE WIRE GUIDE WIRE DQX AV-ASAHI 120907A54S

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Hospitalization| R