BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET

    MDR report key: 2153337 · Received August 21, 2008

    Report

    Report Number
    3005099803-2008-02176
    Event Type
    Malfunction
    Date Received
    August 21, 2008
    Date of Event
    May 1, 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

    A FUNCTIONAL EVAL OF THE RETURNED DEVICE NOTED THAT THE BASKET IS FUNCTIONAL. TO EVALUATE THE REPORTED ISSUE, WATER WAS INJECTED THROUGH THE DEVICE; THE WATER WAS NOTED TO LEAK FROM THE HANDLE, WHERE THE HANDLE IS CONNECTED TO THE HANDLE CANNULA. THE LEAK BASED ON THE OBSERVED LOCATION, IS ATTRIBUTED TO A POOR SEAL (GOVERNED BY AN O-RING) AROUND THE HANDLE CANNULA. THE CAUSE OF THE POOR O-RING SEAL COULD NOT BE DETERMINED. 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

    A TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET DEVICE WAS USED DURING AN UNK PROCEDURE ON (B)(6) 2008. ACCORDING TO THE COMPLAINANT, DURING PREPARATION, "THE DEVICE LEAKED CONTRAST MEDIA FROM THE PROXIMAL SHAFT." THE PROCEDURE WAS COMPLETED WITH ANOTHER TRAPEZOID RX LITHOTRIPTER DEVICE. NO PT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT. AT THE CONCLUSION OF THE PROCEDURE, THE PT'S CONDITION WAS REPORTED AS "GOOD."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TRAPEZOID RX LITHOTRIPTER COMPATIBLE BASKET LQC BOSTON SCIENTIFIC CORPORATION M00510880 11238062

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK