BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RAPID EXCHANGE

    MDR report key: 2904834 · Received January 9, 2013

    Report

    Report Number
    3005099803-2012-06366
    Event Type
    Malfunction
    Date Received
    January 9, 2013
    Date of Event
    November 13, 2012
    Report Date
    December 20, 2012
    Manufacturer
    BOSTON SCIENTIFIC - SPENCER
    Product Code
    GCJ
    PMA / PMN Number
    K970054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT'S AGE IS UNKNOWN; HOWEVER THE PATIENT WAS UNDER 18 YEARS OF AGE. (B)(4) THE INVESTIGATION FINDING: CATHETER TORN. VISUAL EVALUATION OF THE RETURNED DEVICE FOUND THAT THE GUIDEWIRE LUMEN OF THE DEVICE WAS TORN FROM THE DISTAL END OF THE GUIDEWIRE CHANNEL TO THE TIP, SPLITTING THE TIP. A REMNANT OF THE TORN LUMEN WAS ATTACHED APPROXIMATELY 2.2 CM FROM THE DISTAL TIP. THE RO MARKER HAD BEEN DETACHED FROM THE GUIDEWIRE LUMEN AND WAS NOT RETURNED. EXAMINATION OF THE WORKING LENGTH REVEALED WITNESS MARKS INDICATING THAT HE RO MARKER HAD BEEN PLACED INSIDE THE LUMEN DURING MANUFACTURING. THE DAMAGED DISTAL WORKING LENGTH INCLUDING TIP IS LIKELY DUE TO EXCESSIVE FORCE DURING CUSTOMER HANDLING/USAGE. REVIEW AND ANALYSIS OF ALL AVAILABLE INFORMATION INDICATED THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT WAS OPERATIONAL CONTEXT. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE DEVICE HISTORY RECORD REVIEW FOUND THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A RX CANNULA WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2012. ACCORDING TO THE COMPLAINANT, DURING CANNULATION WHEN THE DEVICE WAS OVER THE GUIDEWIRE, THE RADIOPAQUE MARKER CAME OFF THE CANNULA IN THE DUODENUM. THE RADIOPAQUE MARKER AND DEVICE WERE REMOVED FROM THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER RX CANNULA. 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 FINE. THIS EVENT HAS BEEN DEEMED REPORTABLE BASED ON THE INVESTIGATION FINDING: CATHETER TORN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    12897 RAPID EXCHANGE LAPAROSCOPE, GENERAL & PLASTIC SURGERY GCJ BOSTON SCIENTIFIC - SPENCER M00545820 0014839575

    Patients

    Seq Age Sex Outcome Treatment
    1