BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXTRACTOR RX RETRIEVAL BALLOON

    MDR report key: 1191869 · Received October 1, 2008

    Report

    Report Number
    3005099803-2008-04953
    Event Type
    Malfunction
    Date Received
    October 1, 2008
    Date of Event
    September 6, 2008
    Report Date
    September 8, 2008
    Manufacturer
    BOSTON SCIENTIFIC
    Product Code
    FGE
    PMA / PMN Number
    K970052
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE ANALYSIS: THE COMPLAINT SAMPLE WAS NOT RETURNED FOR EVAL AS IT WAS DISPOSED OF AT THE USER FACILITY. DEVICE HISTORY RECORD REVIEW WAS PERFORMED AND NO ISSUES WERE NOTED. THE DEVICE HISTORY RECORD REVIEW CONFIRMS THAT THE DEVICE MET ALL MATERIAL, ASSEMBLY AND PERFORMANCE SPECIFICATIONS. THE MOST PROBABLE ROOT CAUSE IS HANDLING DAMAGE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING AN ENDOSCOPIC PROCEDURE, A BALLOON RUPTURE OCCURRED. THE TARGET LESION WAS IN AN UNSPECIFIED BILE DUCT LOCATION. AN EXTRACTOR RX 12-15 MM RETRIEVAL BALLOON HAD BEEN SELECTED FOR USE; HOWEVER, DURING UNPACKING, IT WAS NOTICED THAT THE BALLOON WAS RUPTURED. THE DEVICE DID NOT COME INTO CONTACT WITH THE PT. THE PROCEDURE WAS COMPLETED WITH AN UNSPECIFIED TYPE OF DIFFERENT DEVICE. THERE WERE NO PT COMPLICATIONS REPORTED WITH THE PT'S CURRENT CONDITION LISTED AS "GOOD".

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXTRACTOR RX RETRIEVAL BALLOON FGE BOSTON SCIENTIFIC M00546940 11831842

    Patients

    Seq Age Sex Outcome Treatment
    1