BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM

    MDR report key: 950007 · Received April 13, 2007

    Report

    Report Number
    6000089-2007-00558
    Event Type
    Malfunction
    Date Received
    April 13, 2007
    Date of Event
    December 29, 2006
    Report Date
    April 4, 2007
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    PMA / PMN Number
    K021630
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: DEVICE ANALYSIS CONFIRMED THAT IT WAS NOT POSSIBLE TO INFLATE THE BALLOON DUE TO A LONGITUDINAL TEAR IN THE BALLOON MATERIAL MEASURING APPROX 6MM IN LENGTH AND RUNNING FROM THE DISTAL EDGE OF THE DISTAL MARKERBAND TO THE DISTAL BALLOON BOND. MICROSCOPIC EXAMINATION OF THE BALLOON MATERIAL AT THE LEAK SITE COULD NOT IDENTIFY ANY ISSUES WITH THE BALLOON OR THE DISTAL MARKERBAND THAT COULD HAVE POTENTIALLY CONTRIBUTED TO THE COMPLAINT INCIDENT. VISUAL EXAMINATION FOUND THAT THAT THE BALLOON HAD BEEN SUBJECTED TO POSITIVE PRESSURE. VISUAL EXAMINATION OF THE DEVICE FOUND THAT THE STENT WAS FREE MOVING ON THE BALLOON AND THAT THE PROXIMAL AND DISTAL STENT STRUTS WERE SLIGHTLY EXPANDED. EXAMINATION OF THE STENT FOUND THAT THERE WERE NO SHARP POINTS OR ANY DAMAGE WITH THE STRUTS THAT COULD HAVE CAUSED A TEAR IN THE BALLOON MATERIAL. EXAMINATION OF THE BALLOON FOUND A FAINT IMPRESSION OF WHERE THE STENT WAS CRIMPED IN ITS CORRECT POSITION. A REVIEW OF THE MFR RECORD FOR BATCH 9131198, SHOWS THAT THE DEVICE MET ITS MATERIAL, ASSEMBLY AND PRODUCT SPEC(S). NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS BATCH NUMBER. THE ROOT CAUSE OF THE COMPLAINT INCIDENT COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    REPORTABLE BASED ON ANALYSIS APPROVED ON 04/04/2007: IT WAS REPORTED THAT DURING A PTA AND STENTING TREATMENT PROCEDURE, THE BALLOON DID NOT INFLATE. NO FURTHER INFO IS AVAILABLE ABOUT, THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY LD PREMOUNTED STENT SYSTEM FGE CATHETER, BILIARY, DIAGNOSTIC FGE BOSTON SCIENTIFIC CORP. NA 9131198

    Patients

    Seq Age Sex Outcome Treatment
    1 *