BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE GUIDEWIRE

    MDR report key: 1160043 · Received September 12, 2008

    Report

    Report Number
    3005099803-2008-04548
    Event Type
    Malfunction
    Date Received
    September 12, 2008
    Date of Event
    August 14, 2008
    Report Date
    August 15, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    EZB
    PMA / PMN Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALTHOUGH THE SUSPECT DEVICE HAS BEEN RETURNED, THE DEVICE EVALUATION HAS NOT BEEN COMPLETED; THE CAUSE OF THE REPORTED MALFUNCTION HAS NOT BEEN UNDETERMINED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION IN 2008, THAT A JAGWIRE GUIDEWIRE DEVICE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIO-PANCREATOGRAPHY (ERCP) PROCEDURE, PERFORMED ON THE DAY BEFORE (A MALE PATIENT; WEIGHT IS UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN "EXPERIENCED FRICTION WHEN MOVING THE DEVICE EITHER IN THE CANNULA OR IN THE SPHINCTEROTOME'S LUMEN." IT WAS ALSO NOTED THAT THE GUIDEWIRE COATING WAS NOT AS "SMOOTH" AS USUAL. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE GUIDEWIRE DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE "STABLE".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE GUIDEWIRE EZB BOSTON SCIENTIFIC CORPORATION M0055658011 11436207

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR