BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    BILIARY BALLOON DILATATION CATHETER

    MDR report key: 1961859 · Received January 14, 2011

    Report

    Report Number
    3005099803-2011-00019
    Event Type
    Malfunction
    Date Received
    January 14, 2011
    Date of Event
    November 2, 2010
    Report Date
    December 23, 2010
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    FGE
    PMA / PMN Number
    K910931
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): VISUAL EVALUATION OF THE RETURNED COMPLAINT DEVICE FOUND NO DAMAGE TO THE CATHETER PORTION OF THE DEVICE. FUNCTIONAL TESTING REVEALED A LEAK IN THE BALLOON PORTION OF THE DEVICE. MICROSCOPIC EXAMINATION CONFIRMED A SMALL TEAR IN THE BALLOON, INDICATING THE BALLOON HAD BURST. THE MOST PROBABLE ROOT CAUSE FOR THIS EVENT IS OPERATIONAL CONTEXT; THIS FAILURE OCCURS WHEN PROCEDURAL FACTORS ENCOUNTERED DURING THE PROCEDURE LIMIT PERFORMANCE OF THE BALLOON (E.G., THE BALLOON COMES INTO CONTACT WITH SHARP EXTERIOR SOURCES). A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS PERFORMED AND CONFIRMED THAT THIS DEVICE MET ALL MATERIAL, ASSEMBLY, AND PRODUCT SPECIFICATIONS. A SEARCH OF THE COMPLAINT DATABASE REVEALED THAT NO SIMILAR COMPLAINTS EXIST FOR THE SPECIFIED LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6), 2010 THAT A MAXFORCE BILIARY BALLOON DILATATION CATHETER WAS USED DURING AN ENDOSCOPIC PAPILLARY BALLOON DILATATION PROCEDURE PERFORMED ON (B)(6), 2010 (PATIENT AGE, GENDER, AND WEIGHT ARE UNKNOWN). ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE BALLOON WOULD NOT FULLY INFLATE WHEN ATTEMPTING TO DILATE THE PAPILLA. THE ACCOUNT CONFIRMED THE BALLOON DID NOT BURST AND THE PROCEDURE WAS COMPLETED WITH ANOTHER MAXFORCE BILIARY BALLOON DILATATION CATHETER. 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. ON (B)(6), 2010 AFTER FINAL EVALUATION OF THE COMPLAINT DEVICE, A SMALL TEAR WAS FOUND IN THE BALLOON INDICATING THE BALLOON HAD BURST WHICH IS CONTRARY TO THE COMPLAINANT'S REPORT THAT THE BALLOON DID NOT BURST. BASED ON THE INVESTIGATION FINDINGS, THIS IS NOW A MDR REPORTABLE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 BILIARY BALLOON DILATATION CATHETER CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC - GALWAY M00567420 13563115

    Patients

    Seq Age Sex Outcome Treatment
    1