BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERSOAKER CATHETER

    MDR report key: 1853222 · Received September 29, 2010

    Report

    Report Number
    2026095-2010-00245
    Event Type
    Other
    Date Received
    September 29, 2010
    Date of Event
    September 5, 2010
    Report Date
    September 7, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE, PART OR LOT NUMBER, A COMPLETE ANALYSIS CANNOT BE CONDUCTED. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. IT WAS REPORTED THAT RESISTANCE WAS NOTED WHEN THE CATHETER WAS REMOVED, RESULTING IN BREAKAGE DURING REMOVAL. THE CATHETER SEGMENT REMAINS IN THE PATIENT AT THE TIME OF THE REPORT. BASED ON THIS INFORMATION RECEIVED, THE TECHNIQUE USED IN THE REMOVAL OF THE CATHETER CONTRIBUTED TO THE REPORTED INCIDENT. I-FLOW HAS PREPARED A TECHNICAL BULLETIN IN ORDER TO PREVENT OR DECREASE CATHETER BREAKS ENTITLED: "TIPS FOR PREVENTING IN-SITU CATHETER BREAKAGE WITH THE ON-Q POST-OP PAIN RELIEF SYSTEM." (1303971, REV. B). THE DIRECTIONS FOR USE (DFU) (1304459, REV. C) PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF A NON-TOXIC, MEDICAL-GRADE MATERIAL THAT MEETS ISO 10993-1 TISSUE COMPATIBILITY GUIDELINES FOR IMPLANTATION OF UP TO 30-DAYS; COMPLICATIONS MAY ARISE IF A CATHETER (OR PORTION THEREOF) IS LEFT IN THE BODY FOR LONGER THAN THIS PERIOD OF TIME. IF ADDITIONAL INFORMATION BECOMES AVAILABLE IN THE FUTURE, WE WILL REOPEN THIS COMPLAINT.

    Description of Event or Problem · 1

    CATHETER BROKE DURING REMOVAL, LEAVING APPROXIMATELY 10CM INSIDE PATIENT. DUAL CATHETERS USED, ONE CAME OUT FINE, ONE BROKE. FRAGMENT NOT REMOVED FROM PATIENT AT THIS TIME. ACTUAL CATHETER IS UNKNOWN. RESISTANCE WAS ENCOUNTERED DURING REMOVAL. PRODUCT NOT SAVED FOR RETURN. PUMP FILLED IN PHARMACY WAS 5001570, LOT 042741. PM040-A TYPICALLY USED FOR SPINE CASES. DR INFORMED THAT REMOVAL OF FRAGMENT IS NOT ANTICIPATED AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORP. PM040-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK