BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 8906053 · Received August 19, 2019

    Report

    Report Number
    9612007-2019-00040
    Event Type
    Malfunction
    Date Received
    August 19, 2019
    Date of Event
    July 23, 2019
    Report Date
    July 23, 2019
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE IP2 INTRODUCER WAS RECEIVED WITH THE LICOX PROBE AND A CODMAN TRANSDUCER STILL INSERTED. INTRODUCER COMPRESSION SEAL IS DAMAGED, DEFORMED, SPLIT ON ONE SIDE WITH A LACK OF MATERIAL. THE HARD PLASTIC STOP (NEXT TO THE COMPRESSION SEAL) IS ALSO DEFORMED. THE DEVICE HISTORY RECORDS OF REF IP2P, LOT 0211603 , SERIAL NUMBER (B)(4) WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. THE COMPLAINT IS VERIFIED. THE MOST LIKELY CAUSE OF THIS DAMAGE IS AN EXCESSIVE FORCE USED TO TIGHTEN THE COMPRESSION CAP WHEN PLACING THE DEVICE. THE EXCESSIVE TIGHTENING OF THE COMPRESSION CAP WAS ALSO OBSERVED ON THE LICOX PROBE: AT AROUND 60MM OF THE TIP, AT THE LEVEL OF THE CLAMPING GASKET (LEVEL OF THE INTRODUCER COMPRESSION SEAL), THE PROBE ALSO IS DEFORMED/SPLIT. DEVICE IDENTIFIER IP2P: (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT YET RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    A PHARMACY ASSISTANT SPECIALIST REPORTED THAT AN IP2P LICOX BRAIN OXYGEN MONITORING PROBE WAS PLACED ON (B)(6) 2019. THE DEVICE WAS DECIDED TO BE REMOVED ON (B)(6) 2019 HOWEVER IT WAS IMPOSSIBLE TO REMOVE THE INTRACRANIAL PRESSURE (ICP) PROBE NOR THE LICOX PROBE FROM THE BOLT. THE BOLT WAS UNSCREWED AND TAKEN OUT IN ORDER TO REMOVE THE PROBES. AFTER REMOVAL, IT SEEMED THAT THE PLASTIC PART OF THE INTRODUCER WAS COMPRESSED WITH CRUMBLED PLASTIC. ADDITIONAL INFORMATION WAS RECEIVED ON 26JUL2019 INDICATING THAT THE (B)(6) FEMALE PATIENT IS AWAKE BUT IMPOSSIBLE FOR THE MOMENT TO HAVE A THOROUGH NEUROLOGICAL EVALUATION. MAGNETIC RESONANCE IMAGING (MRI) WAS DONE BUT THERE'S NO METHOD TO CHECK IF THERE'S ANY INTRACRANIAL PLASTIC PIECES IN THE PATIENT'S HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    700832 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 0211603

    Patients

    Seq Age Sex Outcome Treatment
    1 ICP PROBE