BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80 CM

    MDR report key: 6207643 · Received December 27, 2016

    Report

    Report Number
    2021898-2016-00488
    Event Type
    Malfunction
    Date Received
    December 27, 2016
    Date of Event
    November 28, 2016
    Report Date
    November 28, 2016
    Manufacturer
    MEDTRONIC NEUROSURGERY
    Product Code
    JXG
    UDI-DI
    00613994806628
    PMA / PMN Number
    K862303
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATELY 80 CM OF THE CATHETER WAS RETURNED. THE CATHETER WAS PATENT. HOWEVER, IT DID NOT MEET THE REQUIREMENTS FOR LEAK TESTING. THERE WAS A TEAR OBSERVED APPROXIMATELY 10 CM FROM THE DISTAL END. IT IS UNKNOWN HOW OR WHEN THE DAMAGE OCCURRED. THE CATHETER ALSO MET THE REQUIREMENTS FOR THE TENSILE STRENGTH AND ELONGATION TESTS. THE INSTRUCTIONS FOR USE THAT ACCOMPANY THE DEVICE CAUTIONS THAT LOW TEAR STRENGTH IS A CHARACTERISTIC OF MOST UNREINFORCED SILICONE ELASTOMER MATERIALS, AND THAT CARE MUST BE TAKEN WITH THE HANDLING AND PLACEMENT OF THE SILICONE ELASTOMER CATHETER TUBING TO AVOID CUTS, NICKS, OR TEARS. IT ALSO CAUTIONS THAT TO AVOID POSSIBLE TRANSECTION OF THE CATHETER DURING CATHETER PLACEMENT, THE CATHETER SHOULD NEVER BE WITHDRAWN THROUGH THE TUOHY NEEDLE. IF THE CATHETER NEEDS TO BE WITHDRAWN, THE TUOHY NEEDLE, GUIDEWIRE, AND THE CATHETER MUST BE REMOVED SIMULTANEOUSLY. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS UNAVAILABLE FOR RETURN. THEREFORE AN EVALUATION OF THE DEVICE PERFORMANCE WAS NOT POSSIBLE. A REVIEW OF THE MANUFACTURING RECORDS SHOWED NO ANOMALIES. ALL CATHETERS ARE 100% INSPECTED AT THE TIME OF MANUFACTURE. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO MEDTRONIC NEUROSURGERY THAT THE CATHETER WAS LEAKING OUT OF THE DISTAL PORTION AFTER INSERTION. ACCORDING TO THE REPORT, THE CATHETER WAS REMOVED AND REPLACED WITH ANOTHER CATHETER. THERE WAS NO INJURY TO THE PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    855940 EDM LUMBAR CATHETER BARIUM IMPREGNATED, 80 CM SHUNT, CENTRAL NERVOUS SYSTEM AND COMPONENTS JXG MEDTRONIC NEUROSURGERY E16293 00613994806628

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR