BEUDAMED
    FDA Adverse Event Injury Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER

    MDR report key: 10276190 · Received July 15, 2020

    Report

    Report Number
    9612007-2019-00044
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    November 13, 2019
    Report Date
    November 19, 2019
    Manufacturer
    INTEGRA NEUROSCICENCS IMPLANTS SA
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THE LICOX PROBE WAS RECEIVED WITHOUT ITS PROTECTIVE SHEATH. A MARK (KINK) WAS NOTED AT 12MM FROM THE PROBE TIP. SOME AIR BUBBLES WERE OBSERVED IN THE PROBE ELECTROLYTE SOLUTION, ABOVE THE ACTIVE AREA. PROBE WAS CONNECTED TO A LICOX MONITOR AND PLAUSIBILITY TEST SHOWED OXYGEN MEASURED VALUES WERE LOWER THAN EXPECTED BUT STABLE. THE LICOX PROBE WAS THEN IMMERGED IN WATER, SHOWING SIMILAR RESULTS. MANIPULATION OF THE CABLE AND PROBE AT THE LEVEL OF THE CONNECTORS HAD NO IMPACT ON THE SIGNAL. EACH PROBE IS VERIFIED TO BE WITHIN SPECIFICATIONS AT TIME OF MANUFACTURING AND THIS PROBE SN 452 WAS TESTED WITHIN SPECIFICATIONS AT THE END OF MANUFACTURING PROCESS. THE DEVICE HISTORY RECORDS OF REF IP1P, LOT 211630 WERE REVIEWED AND DID NOT REVEAL ANY ANOMALY THAT COULD EXPLAIN THE REPORTED EVENT. THE COMPLAINT IS VERIFIED, THE RETURNED PROBE IS NOT FUNCTIONAL. HOWEVER, THE REPORTED INSTABILITY (VALUES FROM -15 TO +65MMHG) WAS NOT FOUND DURING TESTING. PROBE IS STABLE BUT DISPLAYS OXYGEN PRESSURE VALUES LOWER THAN EXPECTED. THESE LOWER VALUES CAN BE EXPLAINED BY THE FACT THAT THE PROBE WAS ALREADY USED DURING 5 DAYS ON THE PATIENT (5 DAYS IS THE MAXIMUM ALLOWED TIME FOR USE PER INSTRUCTIONS FOR USE AND WAS RETURNED WITHOUT ITS PROTECTING SHEATH (IMPAIRING THE ELECTROLYTE SOLUTION CONCENTRATION). THE EXACT CAUSE OF THE REPORTED INSTABILITY OF THE PROBE COULD NOT BE DETERMINED BY THE INVESTIGATION. DEVICE IDENTIFIER (B)(4). . BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA (B)(4) HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6) MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    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

    IT WAS REPORTED THAT INCORRECT VALUES (-15 OR 65) WERE READ ON THE IP1P KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER ON (B)(6) 2019. THE PROBE WAS INSERTED ON (B)(6) 2019. SCANNER WAS DONE THE DAY BEFORE THE ISSUE. THEY HAD TO CHANGE THE PROBE WITH ANOTHER ONE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    745202 KIT CONTAINING CC1.P1 AND THE IP1 INTRODUCER LICOX BOLTS CATHETERS & KITS GWM INTEGRA NEUROSCICENCS IMPLANTS SA 0211630

    Patients

    Seq Age Sex Outcome Treatment
    1