BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHRO GUIDEWIRE

    MDR report key: 1474371 · Received July 9, 2009

    Report

    Report Number
    2939204-2009-00543
    Event Type
    Malfunction
    Date Received
    July 9, 2009
    Date of Event
    June 11, 2009
    Report Date
    June 11, 2009
    Manufacturer
    NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    K032146
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXPIRATION DATE: UNK. DEVICE MANUFACTURE DATE: UNK. ADD'L PMA/510 (K): K002907.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING PREPARATION PRIOR TO THE PROCEDURE THE PHYSICIAN NOTED THAT THE GUIDEWIRE COATING WAS PEELING OFF IN HIS HANDS. THERE WERE NO REPORTED CLINICAL CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHRO GUIDEWIRE DQX NEUROVASCULAR DIVISION, BOSTON SCIENTIFIC CORPORATION M00313010 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 SYNCHRO .014 GUIDEWIRE (BOSTON SCIENTIFIC)