BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE GUIDEWIRE

    MDR report key: 1040415 · Received May 7, 2008

    Report

    Report Number
    3005099803-2008-00436
    Event Type
    Malfunction
    Date Received
    May 7, 2008
    Date of Event
    April 4, 2008
    Report Date
    April 7, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    DQX
    PMA / PMN Number
    NA
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS BEEN RETURNED, BUT THE EVAL IS NOT COMPLETE; THEREFORE, A FAILURE ANALYSIS IS NOT AVAILABLE AND THE CAUSE OF THE TIP DETACHMENT IS UNDETERMINED. A SEARCH OF THE CIMPLAINT DATABASE REVEALED NO ADD'L COMPLAINTS RECORDED FOR THIS LOT. THE MARCH 2008 15-MONTH JAGWIRE PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES, WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED.

    Description of Event or Problem · 1

    A JAGWIRE GUIDEWIRE WAS USED DURING STONE EXTRACTION PROCEDURE IN 2008. ACCORDING TO THE COMPLAINANT, FOLLOWING SPHINCTEROTOMY (USING A OLYMPUS CLEVERCUT SPHINCTEROTOME) AND STONE EXTRACTION (USING AN EXTRACTOR RX BALLOON, BOSTON SCIENTIFIC CORP, AND A CRUSHER BASKET CATHETER, ZEON MEDICAL INC.), "IT WAS NOTED [UNDER COMPUTERIZED TOMOGRAPHY] THAT THE DISTAL [TIP OF THE JAGWIRE GUIDEWIRE] BECAME FRACTURED [AND DETACHED]. [THE PHYSICIAN] FAILED TO [RETRIEVE] THE DISTAL TIP WITH THE BASKET AND RETRIEVAL BALLOON. THEREFORE, THE PROCEDURE WAS STOPPED. THE PHYSICIAN WILL TRY TO REMOVE THE DISTAL TIP AFTER A FEW DAYS.' THE DETAILS AND DATE OF THE FOLLOW UP PROCEDURE ARE UNK. THE PT'S CONDITION WAS REPORTED AS "GOOD" FOLLOWING THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE GUIDEWIRE DQX BOSTON SCIENTIFIC CORPORATION M0055658011 8555576

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other