BEUDAMED
    FDA Adverse Event Other Summary report: N

    SILVERSOAKER CATHETER

    MDR report key: 1694212 · Received May 13, 2010

    Report

    Report Number
    2026095-2010-00049
    Event Type
    Other
    Date Received
    May 13, 2010
    Date of Event
    January 1, 2010
    Report Date
    April 19, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFO CONTAINED HEREIN IS BASED ON THE INFO PROVIDED BY THE INITIAL REPORTER. THE DEVICE IS NOT AVAILABLE FOR EVAL AND INVESTIGATION. WITHOUT THE ACTUAL SAMPLE 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 AND THOUGHT THE CATHETER HAD BEEN SUTURED INTO PLACE, RESULTING IN BREAKAGE DURING REMOVAL. THE PHYSICIAN DOES NOT PLAN TO REMOVE THE CATHETER TIP AT THIS TIME AND THE PT IS REPORTED TO BE DOING WELL. BASED ON THIS INFO 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 PT GUIDELINE INSERT, I-FLOW HAS PROVIDED CATHETER REMOVAL INSTRUCTIONS TO ENSURE SAFE REMOVAL (1305285, REV. C). THE DIRECTIONS FOR USE (DFU) (1306078, REV. C) CLEARLY PROVIDE CAUTIONS AND DIRECTIONS ON CATHETER REMOVAL IF RESISTANCE IS ENCOUNTERED. IT IS WORTH NOTING THAT I-FLOW'S CATHETERS ARE MADE OF 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 ADD'L INFO IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A F/U REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT RESISTANCE WAS NOTED BY A PHYSICIAN DURING CATHETER REMOVAL AND BROKE IN A PT THAT HAD A C-SECTION. F/U INDICATED THAT THE PHYSICIAN DECIDED TO LEAVE THE DISTAL PORTION OF THE CATHETER IN THE PT AND TO MONITOR CLOSELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORP. PM020-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 26 YR Other