BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE PRECURSOR

    MDR report key: 1333824 · Received March 5, 2009

    Report

    Report Number
    3005099803-2008-03112
    Event Type
    Malfunction
    Date Received
    March 5, 2009
    Date of Event
    August 31, 2006
    Report Date
    August 31, 2006
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION-MIAMI
    Product Code
    EZB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION REVEALED A DAMAGED SPRING; ONE OF THE COILS IS PROTRUDING. NO OTHER DEFECTS WERE NOTICED. A FUNCTIONAL TEST COULD NOT BE PERFORMED TO THE UNIT, DUE TO THE CONDITION OF THE SPRING. THE COMPLAINT WAS CONFIRMED. THE SPRING OF THE JAG TAIL IS DAMAGED, THEREFORE CONNECTING TO ANOTHER UNIT IS NOT POSSIBLE. DURING THE MANUFACTURING PROCESS, UNITS ARE 100% INSPECTED VERIFYING THE INTEGRITY OF THE SPRING PRIOR TO SHIPPING, AT THIS TIME WE CANT DETERMINE HOW THE DAMAGE OBSERVED TO THE UNIT OCCURRED. THE ASSIGNMENT OF A ROOT CAUSE FOR THIS COMPLAINT IS NOT POSSIBLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND MET ALL SPECIFICATION RELEVANT TO COMPLAINT UPON LOT RELEASE AND HAS NO ANOMALIES RELATED TO COMPLAINT. THE LOT MET ALL SPECIFICATIONS RELEVANT TO THE COMPLAINT UPON LOT RELEASE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE PRECURSOR DEVICE WAS USED DURING A PROCEDURE PERFORMED IN 2006 (PATIENT GENDER, AGE, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, THEY ATTEMPTED TO CONNECT THE DEVICE BUT IT WAS NOT POSSIBLE BECAUSE THE DISTAL END OF THIS DEVICE WAS CLOSED (BLOCKED). THE CLOSED AREA WAS OPENED BY THE NEEDLE, AND THEN THE CONNECTION WAS ATTEMPTED AGAIN BUT IT WAS NOT POSSIBLE. THIS PROCEDURE WAS COMPLETED USING ANOTHER 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 "OKAY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE PRECURSOR INSTRUMENT, MANUAL, SURGICAL, GENERAL USE EZB BOSTON SCIENTIFIC CORPORATION-MIAMI M00556921 0008342280

    Patients

    Seq Age Sex Outcome Treatment
    1 RX TAPERED ERCP CANNULA| EXTRACTION RX RETRIEVAL BALLOON