BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SEGURA BASKET

    MDR report key: 205893 · Received January 13, 1999

    Report

    Report Number
    6000043-1999-00002
    Event Type
    Injury
    Date Received
    January 13, 1999
    Date of Event
    November 11, 1998
    Report Date
    December 14, 1998
    Manufacturer
    MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP.
    Product Code
    FFL
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    IT WAS REPORTED THE BASKET ON THIS CATHETER DETACHED IN THE PT DURING A URETERAL STONE RETRIEVAL PROCEDURE. FOLLOWING SUCCESSFUL ENCAPSULATION OF THE STONE, A HOLMIUM YAG LASER WAS USED TO FRAGMENT THE ENCPASULATED STONE. APPROX ONE WEEK POST PROCEDURE, THE BASKET AND THE STONE WERE REMOVED SURGICALLY WITHOUT INCIDENT. THE PT IS GOOD. THE DEVICE WAS REC'D, EVALUATED AND RETAINED BY THIS MFR. THE ENGINEERING EVAL REVEALED THE DEVICE LENGTH WAS COILED IN A TIGHT LOOP. APPROX 15CM OF THE SHEATH AND 26CM OF THE INNER COIL WERE ATTACHED TO THE DEVICE HANDLE. APPROX 96CM OF THE SHEATH AND 98CM OF THE INNER COIL WERE STRETCHED AND SEPARATED FROM THE REMAINING DEVICE. THE BASKET TIP CANNULA WAS DETACHED FROM THE BASKET AND NOT RETURNED. THE BASKET WIRES WERE SHAPED AS THOUGH BASKET HAD ENCAPSULATED A STONE AT A GIVEN TIME. THREE WIRES APPEARED BROKEN AT THE TIP CANNULA AND THE REMAINING WIRE HAD BROKEN APPROX 8MM FROM WHERE THE TIP WOULD BE LOCATED. THE DISTAL 8MM OF THE WIRE WAS NOT RETURNED FOR EVAL. THE RETURNED WIRES WERE EXAMINED WITH 10X VIEWING DEVICE AND IT WAS NOTED ALL BROKEN EDGES WERE BLACKENED AND APPEARED MELTED INDICATING CONTACT WITH A LASER. SINCE CO'S FOLLOW UP INDICATED THIS DEVICE WAS USED IN CONJUNCTION WITH A HOLMIUM YAG LASER, CO BELIEVES THIS NON-INDICATED USE, USE WITH A LASER, TO HAVE CONTRIBUTED TO THIS EVENT. CO'S DIRECTIONS FOR USE STATE: "THIS DEVICE MUST NOT COME IN CONTACT WITH ANY ELECTRIFIED INSTRUMENT."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SEGURA BASKET STONE RETRIEVAL BASKETS FFL MICROVASIVE UROLOGY A DIV OF BOSTON SCIENTIFIC CORP. NA 1732961

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention