BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JAGWIRE

    MDR report key: 1934790 · Received December 21, 2010

    Report

    Report Number
    3005099803-2010-05311
    Event Type
    Injury
    Date Received
    December 21, 2010
    Date of Event
    November 11, 2010
    Report Date
    December 1, 2010
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA
    Product Code
    EZB
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - THE REPORTED EVENT OF TIP DETACHMENT. (B)(4) - MEDICAL INTERVENTION REQUIRED (STENT PLACEMENT). 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.

    Additional Manufacturer Narrative · 1

    VISUAL INSPECTION WAS PERFORMED. IT WAS OBSERVED THAT 4 CM OF THE DISTAL TIP COATING HAD DETACHED. THE PTFE JACKET NO SHOWED EVIDENCE OF BEING DAMAGED. THE ENTIRE LENGTH OF THE WIRE WAS EXAMINED AND NO ANOMALIES WERE OBSERVED. THE DEVICE WAS SLIGHTLY SCRAPPED AT THE DISTAL SECTION AND REMNANTS OF ADHESIVE WERE FOUND INDICATING THAT THE PEBAX WAS PROPERLY ATTACHED TO THE COREWIRE. IT IS IMPORTANT TO MENTION THAT THE EVENT HAPPENED DURING THE PROCEDURE AND THERE IS NO ALLEGED DAMAGE IN THE WIRE PRIOR TO ITS INSERTION. IT IS POSSIBLE THAT UNSTATED PROCEDURE AND POSSIBLY CLINICAL FACTORS MAY HAVE CONTRIBUTED TO THE EVENT INCLUDING BUT NOT LIMITED TO INTERACTION WITH OTHER DEVICES, HANDLING OF THE DEVICE AND CONDITION OF THE TREATED LESION. ALSO THE REMNANTS OF ADHESIVE FOUND ON THE COREWIRE ON THE DISTAL TIP SHOW A PROPER ADHESION FROM THE PEBAX TO THE COREWIRE; THEREFORE 'OPERATIONAL CONTEXT' IS THE MOST PROBABLE ROOT CAUSE FOR THIS INCIDENT. A DHR (DEVICE HISTORY RECORD) REVIEW WAS PERFORMED AND NO DEVIATION WAS FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAG PRECURSOR GUIDEWIRE WAS USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6) 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE 2-4 CM OF THE HYDRO TIP OF THE GUIDEWIRE DETACHED IN THE PATIENT'S PANCREATIC DUCT. THE PIECE WAS UNABLE TO BE RECOVERED DURING THE PROCEDURE, SO THE DOCTOR DEPLOYED A PLASTIC STENT SO THAT THE TIP COULD FLOW OUT WITH THE BILE. TWO WEEKS LATER, FOLLOW UP CONFIRMED THAT THE TIP HAD BEEN PASSED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAG PRECURSOR. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT AND THE PATIENT'S CONDITION HAS BEEN DESCRIBED AS "STABLE".

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A JAG PRECURSOR GUIDEWIRE WAS USED IN AN ERCP (ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY) PROCEDURE ON (B)(6), 2010. ACCORDING TO THE COMPLAINT, DURING THE PROCEDURE 2-4 CM OF THE HYDRO TIP OF THE GUIDEWIRE DETACHED IN THE PATIENT'S PANCREATIC DUCT. THE PIECE WAS UNABLE TO BE RECOVERED DURING THE PROCEDURE, SO THE DOCTOR DEPLOYED A PLASTIC STENT SO THAT THE TIP COULD FLOW OUT WITH THE BILE. TWO WEEKS LATER, FOLLOW UP CONFIRMED THAT THE TIP HAD BEEN PASSED SUCCESSFULLY. THE PROCEDURE WAS COMPLETED WITH ANOTHER JAG PRECURSOR. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT 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 M0055660010 13218432

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention ULTRATOME| PLASTIC STENT