BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BILIARY BALLOON DILATATION CATHETER

    MDR report key: 1931574 · Received December 17, 2010

    Report

    Report Number
    3005099803-2010-05222
    Event Type
    Injury
    Date Received
    December 17, 2010
    Date of Event
    November 29, 2010
    Report Date
    November 29, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - NON-SURGICAL MEDICAL INTERVENTION REQUIRED. (B)(4) CATHETER BREAK. THE COMPLAINANT INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE, A FAILURE ANALYSIS OF THE COMPLAINT DEVICE CANNOT BE COMPLETED. IF ANY FURTHER RELEVANT INFORMATION IS IDENTIFIED, A SUPPLEMENTAL MEDWATCH WILL BE FILED.

    Description of Event or Problem · 1

    *PLEASE NOTE THAT THIS REPORT INCLUDES INFORMATION REGARDING THREE PROBLEMATIC DEVICES. MANUFACTURER REPORT # 3005099803-2010-05222 ADDRESSES THE REPORTED ISSUE WITH THE MAXFORCE DILATATION CATHETER, WHILE MANUFACTURER REPORT #S 3005099803-2010-05237 AND 3005099803-2010-05238 ADDRESS THE WALLFLEX STENTS. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED TO TRY AND TREAT TWO OCCLUDED WALLFLEX BILIARY STENTS ON (B)(6) 2010. ACCORDING TO THE COMPLAINANT, THE PATIENT HAD TWO WALLFLEX BILIARY STENTS IMPLANTED WITHIN THE PANCREAS AN UNKNOWN DATE (THESE DEVICES THE SUBJECT OF MANUFACTURER REPORT #S 3005099803-2010-05237 AND 3005099803-2010-05238). ALTHOUGH THE PATIENT DID NOT PRESENT WITH ANY SYMPTOMS AND/OR COMPLICATIONS, THEY WERE CHECKED BACK INTO THE HOSPITAL BECAUSE THE TWO WALLFLEX BILIARY STENTS WERE "CLOGGED UP." IN AN EFFORT TO TRY AND CLEAR THE BLOCKAGES, THE PHYSICIAN PLANNED TO USE THE MAXFORCE DILATATION CATHETER (THIS DEVICE THE SUBJECT OF MANUFACTURER REPORT # 3005099803-2010-05222). HOWEVER, PRIOR TO INFLATING THE BALLOON, THE CATHETER OF THE DEVICE GOT STUCK ON THE STRUTS OF THE STENTS; WHEN THE PHYSICIAN TRIED TO REMOVE THE BALLOON, THE CATHETER BROKE 5CM PROXIMALLY FROM THE BALLOON. THE PHYSICIAN NEEDED TO USE A PAIR OF FORCEPS TO REMOVE THE DEVICE FROM THE PATIENT; NO PORTION OF THE DEVICE WAS LEFT WITHIN THE BODY. AT THIS TIME, THE PROCEDURE WAS ABORTED, AND THE PHYSICIAN PLANS TO CONDUCT A TRANSHEPATIC EXAM AT A LATER DATE. THE PATIENT WAS LISTED AS BEING IN STABLE CONDITION. THE PHYSICIAN ADDED THAT THE STENTS WERE NOT DISLOCATED AS A RESULT OF THIS EVENT, AND THAT THEY DID NOT NEED TO BE RE-POSITIONED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567380 13883084

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention