BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM

    MDR report key: 777923 · Received August 30, 2006

    Report

    Report Number
    6000093-2006-01693
    Event Type
    Malfunction
    Date Received
    August 30, 2006
    Date of Event
    June 8, 2005
    Report Date
    June 14, 2005
    Manufacturer
    BOSTON SCIENTIFIC CORP.
    Product Code
    FGE
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT ANALYSIS COULD NOT VERIFY THE COMPLAINT. THE CATHETER WAS PURGED COMPLETELY OF AIR AND THE BALLOON WAS INFLATED WITH WATER TO ITS RATED BURST PRESSURE. THE CATHETER WAS PRESSURIZED WITHOUT SIGNIFICANT LOSS OF PRESSURE. WHEN THE CATHETER WAS SUBJECTED TO A VACUUM, THE BALLOON DEFLATED NORMALLY AND THERE WAS NO COMPROMISE OF THE GENERATED VACUUM. THE SHOP FLOOR PAPERWORK FOR BATCH 7110064 HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. THE SFP REVIEW CONFIRMS THAT THIS DEVICE MET MATERIAL, ASSEMBLY, AND PERFORMANCE SPECIFICATIONS. NO OTHER COMPLAINTS HAVE BEEN RECEIVED FOR THIS PARTICULAR BATCH OF DEVICES. THE ROOT CAUSE OF THE DIFFICULTIES ENCOUNTERED DURING THE PROCEDURE COULD NOT BE DETERMINED.

    Description of Event or Problem · 1

    UPON FURTHER REVIEW OF OUR FILES, IT WAS DETERMINED THAT THE COMPLAINT ASSOCIATED WITH THIS MEDWATCH WAS FILED UNDER THE Q3 2005 ASR REPORT FOR PERIPHERAL BALLOON RUPTURES, RATHER THAN AS AN INDIVIDUAL MDR. THIS MDR HAS BEEN CREATED TO CORRECT THAT ERROR. IT WAS REPORTED THAT THE BALLOON OF THE EXPRESS BILIARY SD 7.0X15X90CM STENT DELIVERY SYSTEM RUPTURED DURING STENT DEPLOYMENT. THE PHYSICIAN USED AN ULTRA SOFT BALLOON TO SUCCESSFULLY COMPLETE THE PROCEDURE WITH NO PATIENT COMPLICATIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXPRESS BILIARY SD PREMOUNTED STENT SYSTEM BILIARY STENT SYSTEM FGE BOSTON SCIENTIFIC CORP. NA 7110064

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN