BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT CONTAINING CC1 P1 AND THE VK5.2 INTRODUCER

    MDR report key: 4877403 · Received June 26, 2015

    Report

    Report Number
    9617494-2015-00010
    Event Type
    Death
    Date Received
    June 26, 2015
    Report Date
    June 4, 2015
    Manufacturer
    GMS - GESELLSCHAFT FUR MEDIZINISCHE SODENTECHNIK
    Product Code
    GWM
    PMA / PMN Number
    K053244
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 09/16/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE, REVIEW OF DEVICE HISTORY RECORDS, REVIEW OF COMPLAINTS HISTORY. RESULTS: AN OPTICAL INSPECTION AFTER OPENING THE PACKAGE SHOWED THAT THE PROBE WAS CUT OFF APPR. 50MM BEFORE THE FRONT LUER LOCK. DUE TO THE DESTROYING DAMAGE OF THE CATHETER A PERFORMANCE TEST COULDN¿T BE PERFORMED. THE ONLY FEASIBLE STEP/TEST WAS MEASURING THE WIRES (ANODE, CATHODE) TO THE CONNECTION SITE OF THE CATHETER. BOTH WIRES AND THE CONNECTOR OF THE CATHETER DON¿T SHOW ANY DAMAGES APART FROM THE CUTTING. THERE IS NO INDICATION OF INACCURATE MEASUREMENTS OF THE CATHETER. THE DHR OF THE MENTIONED PRODUCT WAS REVIEWED. CC1.P1 (LOT: 080115; SN: (B)(4)); NO ABNORMALITIES COULD BE DETERMINED. NO TREND COULD BE DETERMINED AFTER CHECKING THE TRACKWISE DATABASE. CONCLUSION: THE (B)(4) ARRIVED IN DAMAGED SITUATION CAUSED BY THE CLINICAL PERSONAL. DUE TO THAT A PERFORMANCE TEST WAS IMPOSSIBLE. THE REMAINING TESTS DIDN¿T SHOW ANY INDICATION OF INACCURATE MEASUREMENTS.

    Description of Event or Problem · 1

    THE CATHETER FAILED OXYGEN TEST AND WAS READING VERY INACCURATE. A SECOND CATHETER WAS PLACED NEXT DAY AND WORKED FINE. ADDITIONAL INFORMATION WAS BEEN REQUESTED AND ON (B)(6)2015, THE FOLLOWING WAS PROVIDED: ON (B)(6)2015, THE CATHETER WAS IMPLANTED ON A (B)(6) MALE PATIENT WITH TRAUMATIC BRAIN INJURY. A CT SCAN WAS PERFORMED AFTER PLACEMENT SHOWING IT WAS IN PROPER PLACEMENT. IT WAS REPORTED THAT ON (B)(6) 2015- (B)(6) 2015, PATIENT FIO2 (FRACTION OF INSPIRED OXYGEN) WAS INCREASED TO 100% AS WELL AS PEEP (POSITIVE END-EXPIRATORY PRESSURE) INCREASED TO 10 AND IT DID NOT RESULT IN AN INCREASE IN THE PBO2 (BRAIN TISSUE OXYGENATION). INACCURATE READINGS OF 2-3 WERE RECEIVED. THE CATHETER NEVER FUNCTIONED PROPERLY FROM THE MOMENT IT WAS PLACED. A NEW CATHETER WAS PLACED VIA THE SAME BURR HOLE. THE INITIAL CATHETER WAS CUT WHEN THEY WERE PLACING THE NEW ONE. PATIENT OUTCOME WAS REPORTED AS EXPIRED. THE CUSTOMER DID NOT DISCLOSE DETAILS REGARDING THE PATIENT'S DEATH WHEN REQUESTED. THE CUSTOMER DID STATE THAT THE CATHETER DID NOT LEAD TO THE DEATH OF THE PATIENT. NO OTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    414276 KIT CONTAINING CC1 P1 AND THE VK5.2 INTRODUCER LICOX BOLTS CATHETERS AND KITS GWM GMS - GESELLSCHAFT FUR MEDIZINISCHE SODENTECHNIK 080115

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR Death| R