BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 2150280 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02085
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    April 30, 2008
    Report Date
    May 1, 2008
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    LQC
    PMA / PMN Number
    K040447
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPLAINANT WAS NOT ABLE TO PROVIDE THE BATCH NUMBER OF THE DEVICE; THEREFORE, THE DEVICE MANUFACTURE DATE IS UNKNOWN. A VISUAL EXAMINATION OF THE RETURNED DEVICE REVEALED A LARGE AMOUNT OF CONTRAST RESIDUE THAT PREVENTED PROPER INVESTIGATION OF THE DEVICE. THEREFORE, THE CAUSE OF THE REPORTED MALFUNCTION IS UNDETERMINED. THE (B)(6) 2008 15-MONTH LITHOTRIPTER BASKET PRODUCT FAMILY COMPLAINT TREND REPORT, INCLUSIVE OF ALL FAILURE MODES WAS REVIEWED; NO UNFAVORABLE TREND WAS NOTED. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION ON (B)(6) 2008 THAT A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET WAS USED DURING A PROCEDURE TO RETRIEVE STONES ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, "IT WAS NOTICED THAT THE CONTRAST MEDIA DID NOT EXIT FROM THE TIP OF THE DEVICE, BUT LEAKED FROM THE HANDLE." THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510880 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK