BEUDAMED
    FDA Adverse Event Other Summary report: N

    ON-Q SILVERSOAKER CATHETER

    MDR report key: 1674978 · Received April 30, 2010

    Report

    Report Number
    2026095-2010-00040
    Event Type
    Other
    Date Received
    April 30, 2010
    Date of Event
    March 30, 2010
    Report Date
    April 1, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K051401
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE INFORMATION CONTAINED HEREIN IS BASED ON THE INFORMATION PROVIDED BY THE INITIAL REPORTER AND PRODUCT EVALUATION. ONE SMALL PORTION OF A CATHETER WAS RECEIVED FOR EVALUATION AND INVESTIGATION. THE VISUAL INSPECTION FOUND THAT A 1.25" PIECE OF THE DISTAL INFUSION SEGMENT WAS RETURNED. THE CATHETER SEGMENT HAD A STRETCHED SEGMENT NEXT TO A NON-STRETCHED SEGMENT, INDICATING THE CATHETER HAD BEEN SECURED/HELD IN PLACE, AND BROKE AFTER STRETCHING DURING REMOVAL. THE BEST EVIDENCE INDICATES THAT THE CATHETER BROKE DUE TO HIGH RESISTANCE DURING THE REMOVAL PROCESS. AS NO LOT NUMBER WAS PROVIDED, THE DEVICE HISTORY RECORD AND LOT HISTORY CANNOT BE REVIEWED. BASED ON THIS INFORMATION RECEIVED, THE TECHNIQUE USED BY THE DOCTOR IN THE REMOVAL OF THE CATHETER MOST LIKELY 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 PATIENT 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 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 THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    RESISTANCE WAS NOTED BY THE PHYSICIAN DURING CATHETER REMOVAL IN THE DOCTOR'S OFFICE AND BROKE ON (B)(6) 2010 LEAVING THE DISTAL PORTION OF THE CATHETER IN THE PATIENT. DOCTOR PERFORMED A PROCEDURE ON (B)(6) 2010 AND RETRIEVED THE DISTAL PORTION. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-Q SILVERSOAKER CATHETER CATHETER BSO I-FLOW CORP. PM025-A UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Other| R