BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1840262 · Received September 21, 2010

    Report

    Report Number
    3005099803-2010-04053
    Event Type
    Malfunction
    Date Received
    September 21, 2010
    Date of Event
    June 17, 2010
    Report Date
    September 7, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) "DEVICE OR DEVICE COMPONENT DAMAGED BY ANOTHER DEVICE" FOR THE REPORTED EVENT OF TIP DAMAGED. A VISUAL EXAMINATION REVEALED THAT APPROXIMATELY .5CM OF PEBAX TIP MATERIAL ARE HANGING FROM THE EXPOSED COREWIRE. THE TRANSITION STEP OF THE PEBAX TIP IS ALSO EXPOSED, AND THE PTFE FLARE HAD BEEN PUSHED BACK. THE COREWIRE WAS SLIGHTLY SCRAPED AND THE PRESENCE OF ADHESIVE WAS CONFIRMED. THE OD OF THE GUIDEWIRE WAS MEASURED AT THREE LOCATIONS AND IS WITHIN OD SPECIFICATIONS. THE CONDITION OF THE RETURNED UNIT WAS CONSISTENT WITH THE CUSTOMER COMPLAINT THAT "SOME COATING ON THE DISTAL TIP OF THE GUIDEWIRE WAS DAMAGED". HOWEVER, BASED ON THE INVESTIGATIONS RESULTS OF "THE PEBAX HAD DETACHED FROM THE COREWIRE", THE DEVICE DAMAGE IS GREATER THAN ANTICIPATED OR DESCRIBED. THEREFORE, THE MOST PROBABLE ROOT CAUSE IS OPERATIONAL CONTEXT. A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT. THE INSTRUCTIONS FOR USE STATE: "DO NOT USE WITH METAL-TIP CATHETERS. WITHDRAWING THE GUIDEWIRE THROUGH A METAL TIP CATHETER MAY DAMAGE SURFACE OF GUIDEWIRE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) PROCEDURE PERFORMED ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING WITHDRAWAL OF THE GUIDEWIRE FROM ANOTHER MANUFACTURER'S CANNULA IN THE COMMON BILE DUCT, THE COATING OF THE GUIDEWIRE'S DISTAL TIP WAS OBSERVED TO BE DAMAGED. NO MATERIAL FELL INTO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAGWIRE GUIDEWIRE. 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. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; "PORTIONS OF THE TIP WERE DETACHED."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 JAGWIRE STYLET FOR CATHETER, GASTRO-UROLOGY EZB BOSTON SCIENTIFIC - MIAMI M0055658010 12764811

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR (B)(4) CANNULA