BEUDAMED
    FDA Adverse Event Other Summary report: N

    IO-FLEX CONTRA PROBE

    MDR report key: 2170156 · Received June 28, 2011

    Report

    Report Number
    3006324586-2011-00010
    Event Type
    Other
    Date Received
    June 28, 2011
    Date of Event
    May 31, 2011
    Report Date
    June 1, 2011
    Manufacturer
    BAXANO, INC.
    Product Code
    HAE
    PMA / PMN Number
    K100958
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SUMMARY OF PRODUCT INVESTIGATION: A CONTRA PROBE (IO-CP45 LOT 11030906) WAS RETURNED (RMA (B)(4)) FOR INVESTIGATION UNDER COMPLAINT (B)(4). IT WAS STATED THAT A DURAL TEAR OCCURRED FROM THE SURGEON PUSHING THE PROBE DORSAL INTO THE LAMINECTOMY DEFECT AT L4/5. A TEAR WAS NOTED IN 2 PLACES. THE TEARS WERE CLOSED VIA SUTURE REPAIR AND THE CASE PROCEEDED WITH DECOMPRESSION OF L4/5 AND L3/4 VIA IPSI APPROACH. NO REPORT OF DEVICE MALFUNCTION WAS RECEIVED. INVESTIGATION FINDINGS: THE DEVICE (CONTRA PROBE RETURNED WITH STYLET) WAS DECONTAMINATED (CIDEX) FOLLOWED BY THE INSPECTION OF THE DEVICE FUNCTIONAL CHARACTERISTICS. THE DEVICE APPEARED TO BE FUNCTIONAL AND THAT IT MET PRODUCT SPECS. THERE WAS MILD SKIVING (SCRAPING OF THE PEBAX CATHETER JACKET AGAINST THE STAINLESS STEEL CANNULA OF THE PROBE) VISIBLE ON THE CONVEX SIDE OF THE CATHETER. NO OTHER DAMAGE WAS NOTED. THE PROBABLE ROOT CAUSE OF THE MILD SKIVING INVOLVED THE HYPEREXTENSION OF THE CATHETER WHICH CAUSED MINOR DAMAGE TO THE PEBAX UPON RETRACTION.

    Description of Event or Problem · 1

    ON (B)(6) 2011, A (B)(6) FEMALE PT UNDERWENT DECOMPRESSION SURGERY AT THE RIGHT L3-4, L4-5, AND LEFT L2-3 LUMBAR LEVELS. AFTER A COMPLETE LAMINECTOMY WAS PERFORMED AT L4, THE IO-FLEX CONTRA PROBE WAS INTRODUCED AT THE LEFT L4-5 LUMBAR LEVEL AND A SMALL DUROTOMY OCCURRED IN THE MIDLINE WITH 2 SMALL POINTS OF EROSION IN THE DURA. THE SURGEON STATED THAT THE DURAL TEAR WAS CAUSED BY PUSHING THE PROBE CANNULA DORSAL INTO THE LAMINECTOMY AT L4/5. THE DUROTOMY WAS CLOSED WITH A 5-0 SILK SUTURE AND THERE WAS NO CSF LEAKING AFTER CLOSURE. THE SURGEON PROCEEDED WITH LUMBAR DECOMPRESSION OF OTHER FORAMENS. FIBRIN GLUE WAS PLACED OVER THE DUROTOMY SITE AND 80 MG OF DEPO-MEDROL INFUSED IN THE EPIDURAL SPACE PRIOR TO CLOSING. PT WAS SEEN IN OFFICE TWO WEEKS POST PROCEDURE AND WAS NOTED TO BE DOING WELL. THERE WAS NO REPORT OF DEVICE MALFUNCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 IO-FLEX CONTRA PROBE NONE HAE BAXANO, INC. IO-CP45 11030906

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Other