BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1954671 · Received January 10, 2011

    Report

    Report Number
    3005099803-2011-00035
    Event Type
    Malfunction
    Date Received
    January 10, 2011
    Date of Event
    December 21, 2010
    Report Date
    December 21, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RECEIVED FOR ANALYSIS. UPON RECEIPT AND COMPLETION OF THE FAILURE ANALYSIS OF THE COMPLAINT DEVICE, IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    THIS REPORT PERTAINS TO ONE OF TWO COMPLAINTS (MFR. REPORT # 3005099803-2011-00035 & MFR REPORT # 3005099803-2011-00036) THAT OCCURRED DURING THE SAME PROCEDURE. IT WAS REPORTED TO BOSTON SCIENTIFIC THAT TWO JAGWIRE PRECURSOR GUIDEWIRES MALFUNCTIONED DURING A PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING A SPHINCTEROTOMY PROCEDURE OF A COMMON BILE DUCT STRICTURE, THE PHYSICIAN WAS NEGOTIATING THE FIRST JAG PRECURSOR GUIDEWIRE INTO THE DUCT WHEN THE HYDROPHILIC TIP DETACHED. THE PHYSICIAN REMOVED THE GUIDEWIRE AND ATTEMPTED WITH A SECOND JAG PRECURSOR GUIDEWIRE, BUT THE SAME EVENT OCCURRED. A THIRD JAG PRECURSOR GUIDEWIRE WAS THEN USED AND SUCCESSFULLY NEGOTIATED THE DUCT. NO ACTION WAS TAKEN TO TRY TO RECOVER EITHER TIP. THERE WERE NO PATIENT COMPLICATIONS AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - COSTA RICA M0055658011 13488145

    Patients

    Seq Age Sex Outcome Treatment
    1 38 YR