BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    WALLFLEX? BILIARY

    MDR report key: 4242774 · Received November 11, 2014

    Report

    Report Number
    3005099803-2014-03596
    Event Type
    Malfunction
    Date Received
    November 11, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K083627
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GB
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTED EVENT OF STENT RETRIEVAL LOOP DAMAGED. REPORTED EVENT OF STENT UNRAVELED. REPORTED EVENT OF STENT DIFFICULT TO REMOVE. REPORTED EVENT OF STENT BLOCKED/OCCLUDED. THE COMPLAINANT INDICATED THAT THE DEVICE WAS DISPOSED AND WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2014 THAT A WALLFLEX FC BILIARY STENT RMV WAS IMPLANTED IN THE COMMON BILE DUCT DURING AN ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) WITH METAL STENT PLACEMENT PROCEDURE PERFORMED ON (B)(6) 2014. ACCORDING TO THE COMPLAINANT, THE STENT WAS IMPLANTED TO TREAT A BENIGN BILIARY STRICTURE. THERE WERE NO REPORTED ISSUES DURING THE INITIAL STENT PLACEMENT. REPORTEDLY, 8 MONTHS FOLLOWING STENT PLACEMENT (EXACT DATE UNKNOWN) THE PATIENT CAME IN FOR A SCHEDULED STENT REMOVAL PROCEDURE. DURING THE STENT REMOVAL PROCEDURE, THE PHYSICIAN NOTED TISSUE INGROWTH WITHIN THE STENT DISTALLY AT THE AMPULLA. THE PHYSICIAN ATTEMPTED TO REMOVE THE STENT, HOWEVER, THE RETRIEVAL LOOP SNAPPED, THE STENT WAS DIFFICULT TO REMOVE AND THE STENT WIRES STARTED TO UNRAVEL. A SNARE WAS THEN USED TO REMOVE THE STENT AND THE STENT WAS SUCCESSFULLY REMOVED. 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. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    725100 WALLFLEX? BILIARY CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00570480 16369254

    Patients

    Seq Age Sex Outcome Treatment
    1