BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER, SPINE-INTRADISCAL

    MDR report key: 818526 · Received November 12, 2004

    Report

    Report Number
    1216828-2004-00014
    Event Type
    Malfunction
    Date Received
    November 12, 2004
    Date of Event
    October 13, 2004
    Report Date
    November 12, 2004
    Manufacturer
    SMITH & NEPHEW INC., ENDOSCOPY DIVISION
    Product Code
    LNY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS BEING RETURNED FOR EVALUATION THEREFORE, NO DETERMINATION COULD BE MADE FOR THE REPORTED DEVICE FAILURE.

    Description of Event or Problem · 1

    CATHETER SHEARED OFF IN DISC. SALES REP STATED THE CATHETER WAS ADVANCED, THEN WHEN CUSTOMER TRIED TO PULL IT BACK IT SHEERED OFF. SALES REP MENTIONED HE THOUGHT THERE MIGHT HAVE BEEN A KINK IN IT. SALES REP INDICATED THAT THE PATIENT WAS FEMALE; THE SURGEON USED TWO CATHETERS; THE FIRST ONE WAS INTRODUCED INTO THE LEFT SIDE OF THE DISC AND REMOVED; THE SECOND CATHETER WAS INTRODUCED FROM THE OTHER SIDE AND WITH THE INTRODUCER STILL IN PLACE, THE SURGEON BEGAN MOVING THE CATHETER AROUND WITHIN THE DISC. UPON REMOVAL OF BOTH THE INTRODUCER AND CATHETER TOGETHER FROM THE PATIENT, IT WAS NOTED THAT THE TIP OF THE CATHETER HAD BROKEN OFF AND REMAINED IN THE DISC. THE SURGEON ELECTED NOT TO RETRIEVE THE BROKEN PIECE AND NO FUTURE SURGERY IS PLANNED. SALES REP. INDICATED THAT THE PATIENT IS DOING FINE. DML 11/12/2004.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CATHETER, SPINE-INTRADISCAL CATHETER LNY SMITH & NEPHEW INC., ENDOSCOPY DIVISION 7209599 50042968

    Patients

    Seq Age Sex Outcome Treatment
    1 YR Other