BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CODMAN LUMBAR CATHETER KIT

    MDR report key: 3178118 · Received June 19, 2013

    Report

    Report Number
    1226348-2013-19028
    Event Type
    Injury
    Date Received
    June 19, 2013
    Date of Event
    May 17, 2013
    Manufacturer
    CODMAN & SHURTLEFF, INC.
    Product Code
    JXG
    PMA / PMN Number
    PK954021
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION, A FOLLOW UP REPORT WILL BE FILED.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT INITIALLY THE PRODUCT WAS REPORTED AT 82-1721, HOWEVER DURING THE INVESTIGATION IT WAS DETERMINED THAT THE DEVICE SUBJECT OF THE COMPLAINT WAS ACTUALLY THAT OF PRODUCT 82-1707. TWO SEGMENTS (10" & 2 1/4" LONG) OF A LUMBAR CATHETER WERE RETURNED FOR EVALUATION. NOTE THAT THE ENTIRE LUMBAR CATHETER LENGTH IS 31 1/2"; THEREFORE, 19 1/4" IS MISSING. THE RETURNED LUMBAR CATHETER IS CUT/BROKEN AT 2 1/4" FROM THE DISTAL END. THE CAUSE(S) OF THE CUT/BREAKAGE COULD NOT BE DETERMINED. A REVIEW OF THE LOT HISTORY RECORDS CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. IT WAS ALSO NOTED THAT THIS APPEARS TO BE AN ISOLATED EVENT AS THIS IS THE SECOND COMPLAINT FOR THIS TYPE OF ISSUE FOR THIS PRODUCT CODE THAT HAS BEEN REPORTED IN THE LAST FIVE YEARS. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THERE WAS AN ISSUE WITH THE CATHETER. HOWEVER, HE DOES NOT BELIEVE THAT IS MANUFACTURING RELATED. THE CATHETER SNAPPED WHEN IT WAS PULLED DURING A THORACIC ENDOSCOPIC PROCEDURE. IT WAS ALSO NOTED THAT IT APPEARS THAT THE BREAKAGE IS ASSOCIATED WITH PATIENT ANATOMY. THE PATIENT HAD BACK SURGERY AND THE VERTEBRAL BODY COLLAPSED AND CAUSED PINCHING OF THE CATHETER AND BROKE THE DEVICE. THE LOOSE PART WAS RETRIEVED WITH ADDITIONAL SURGERY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277958 CODMAN LUMBAR CATHETER KIT SHUNT, CENTRAL NERVOUS SYSTEM & COMPS JXG CODMAN & SHURTLEFF, INC. 154518

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention