BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    JAGWIRE

    MDR report key: 1844177 · Received September 24, 2010

    Report

    Report Number
    3005099803-2010-03955
    Event Type
    Malfunction
    Date Received
    September 24, 2010
    Date of Event
    July 7, 2010
    Report Date
    September 9, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MIAMI
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) RELATES TO (B)(4) "PEELED" FOR THE REPORTED EVENT OF TIP PEELED. A VISUAL EXAMINATION REVEALED THAT 1 CM PEBAX IS DETACHED/MISSING FROM DISTAL TIP EXPOSING THE COREWIRE. THE REMAINING PEBAX IS SKIVED. TRACES OF GLUE WERE FOUND ON THE EXPOSED COREWIRE INDICATING THAT THE PEBAX WAS PROPERLY ADHERED TO THE COREWIRE. THE CONDITION OF THE RETURNED INCIDENT DEVICE WAS NOT FULLY CONSISTENT WITH THE COMPLAINT THAT THE TIP WAS PEELED. THE MOST PROBABLE ROOT CAUSE IS "CAUSED BY OTHER DEVICE". A REVIEW OF THE DEVICE HISTORY RECORD CONFIRMS THAT THE DEVICE MET ALL MANUFACTURING SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO OTHER COMPLAINTS EXIST FOR THE SPECIFIED LOT. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; (PEBAX IS DETACHED/MISSING). THE INSTRUCTIONS FOR USE INSTRUCT: "DIP THE DISTAL TIP (THE NON STRIPED DARK PORTION) IN STERILE WATER TO ACTIVATE THE HYDROPHILIC COATING. THIS WILL MAKE THE COATING LUBRICIOUS FOR SELECTIVE CANNULATION. PRIOR TO USE, INSPECT THE GUIDEWIRE BEFORE USING FOR THE FOLLOWING: ROUGHNESS OR ABRASION AT THE TIP. KINKING ALONG THE LENGTH OF THE GUIDEWIRE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAGWIRE GUIDEWIRE WAS USED DURING THE REMOVAL OF BILE DUCT STONES FROM THE COMMON BILE DUCT ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, DURING PREPARATION OF THE DEVICE OUTSIDE THE PATIENT THEY INSERTED THE GUIDEWIRE INTO THE TIP OF A TANDEM XL CANNULA. WHEN THE PHYSICIAN WITHDREW THE GUIDEWIRE FROM THE TANDEM XL CANNULA, ABOUT 1 CM OF THE TUNGSTEN COATING OF THE GUIDEWIRE WAS PEELED OFF AND THEY SAW THE COREWIRE OF THE GUIDEWIRE. ADDITIONAL INFORMATION REVEALED THAT THE TIP WAS PEELING LIKE A BANANA IS PEELED. 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 GOOD. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; "1 CM PEBAX IS DETACHED/MISSING ".

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1