BEUDAMED
    FDA Adverse Event Other Summary report: N

    TUNNELER, DISPOSABLE

    MDR report key: 1760971 · Received July 7, 2010

    Report

    Report Number
    2026095-2010-00073
    Event Type
    Other
    Date Received
    July 7, 2010
    Date of Event
    June 9, 2010
    Report Date
    June 17, 2010
    Manufacturer
    I-FLOW CORP.
    Product Code
    BSO
    PMA / PMN Number
    K063234
    Product Problem
    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 AND PRODUCT EVAL. TWO SPLIT, USED SHEATHS WERE REC'D FOR EVAL AND INSTIGATION. THE VISUAL INSPECTION OF SHEATH #2 FOUND NO DEFECTS. BOTH SHEATHS WER PEELED ENTIRELY WITHOUT FRAYING, AS DESIGNED. SHEATH #1 WAS STRETCHED AT ITS MID-BODY AND BROKEN OFF AT THE DISTAL END. THE TAB OF SHEATH #1 WAS ALSO REC'D BROKEN. A STRETCHED SECTION INDICATES THAT THE SHEATH WAS MOST LIKELY SECURED, SO WHEN IT WAS PULLED AND PEELED, IT BROKE. THE BEST EVIDENCE INDICATES THAT SHEATH #1 WAS PULLED AND MET HIGH RESISTANCE UNTIL IT BROKE OFF AT ITS DISTAL END. A REVIEW OF THE LOT HISTORY FOUND NO OTHER COMPLAINTS FOR THE REPORTED LOT NUMBER. IF ADD'L INFO THAT IS PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW WILL SUBMIT A FOLLOW-UP REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE TUNNELER SHEATH BROKE OFF WHILE PEELING BACK IN THE PT BY THE SURGEON. THE DISTAL PORTION OF THE SHEATH REMAINS IN THE PT AND WAS NOT REMOVED. THE PT'S CURRENT CONDITION IS REPORTED TO BE GOOD AND DID NOT REQUIRE ADD'L TREATMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TUNNELER, DISPOSABLE TUNNELER BSO I-FLOW CORP. T16X12 884875

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other