BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SUBDURAL POST CRANIOTOMY ICP MONITORING KIT

    MDR report key: 5138707 · Received October 8, 2015

    Report

    Report Number
    2023988-2015-00040
    Event Type
    Malfunction
    Date Received
    October 8, 2015
    Date of Event
    August 27, 2015
    Report Date
    September 15, 2015
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED FROM THE DISTRIBUTOR ON 13OCT2015: THE PRIMARY DOCTOR OF NEUROSURGERY AND CLINICAL ENGINEER PERFORMED THE PROCEDURE. THEY DOCTOR HAS PLACED CAMINO PRODUCTS APPROXIMATELY 10-20 TIMES. THE CATHETER WAS ZEROED TO ATMOSPHERE BY USING THE ZEROING TOOL PROVIDED PRIOR TO IMPLANTATION. THE CATHETER AND CABLE WERE SECURED TO THE SHEETS BY A CLIP. THE PATIENT WAS NOT MOVED AT ANY POINT BEFORE THE ISSUE WAS DISCOVERED. THE CATHETER WAS REMOVED AFTER THE INCIDENT ON (B)(6) 2015. THERE WAS NO PATIENT HARM OR INJURY. SINCE THE CATHETER WAS REMOVED, THE PATIENT¿S ICP PRESSURE OF -29 WAS MEASURED WITH AMBIENT AIR. THE 1104G CATHETER WAS NOT REPLACED BECAUSE IT WOULD REDUCE "THE BURDEN OF RE-SURGERY". IT WAS CONFIRMED THAT CAM01 MONITOR DID NOT HAVE ANY PROBLEMS, IT WORKED CORRECTLY AT THE HOSPITAL. THERE WERE NO ERROR MESSAGES DISPLAYED BY THE CAM01 DURING THE INCIDENT. LINKED TO MFG REPORT NUMBER: 8010219-2015-00042.

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12/08/2015. THE INVESTIGATION INCLUDED: METHODS: EVALUATION OF ACTUAL DEVICE; REVIEW OF DEVICE HISTORY RECORDS; REVIEW OF COMPLAINTS HISTORY. RESULTS: CATHETER (B)(4) IS BELONGED TO 110-4G, LOT 305000297645, MFG DATE 11FEB 2014, AND WILL BE EXPIRED ON 31-JAN-2017. A REVIEW LOT 305000297645 INDICATES THAT THE CATHETER MET REQUIREMENTS BEFORE RELEASED TO FINISHED GOODS COMPLAINT HISTORY, MODEL 110-4XXX, FROM OCT-2014 THROUGH SEP-2015 REVIEWED; THERE WERE (B)(4) OTHER COMPLAINTS THAT ISSUED WITH COMPLAINT CODE (B)(4) , AND EIGHT OF THEM WERE CONFIRMED. THE NUMBER OF UNITS, MODEL 110-4XXX, ((B)(4)) OCT-2014 THROUGH SEP-2015 DIVIDED BY THE NUMBER OF CONFIRMED REPORTS (08) AND MULTIPLIED BY 100 RESULTS IN A FAILURE RATE PERCENTAGE (B)(4). CONCLUSION: THE CUSTOMER COMPLAINT THAT THE CATHETER WAS READING NEGATIVE PRESSURE AFTER EXPLANTING FROM THE PATIENT WAS VERIFIED. THE INVESTIGATION WAS PERFORMED AND THE CATHETER WAS TESTED FOR FUNCTIONALITY AND FAILED. UPON FURTHER VISUAL INSPECTION IT WAS NOTED THAT PARTICULATES WERE LODGED INSIDE THE BELLOWS OF THE CATHETER. THE INVESTIGATOR REMOVED THE PARTICULATES AND RETESTED THE CATHETER FOR FUNCTIONALITY, THIS TIME PASSING ALL FUNCTIONAL TEST CRITERIA. THE CATHETER WAS TESTED FOR FORWARD/REVERSE VOLTAGE LEAKAGE AND MET THE TEST CRITERIA. BASED ON THE RESULTS OF THIS INVESTIGATION, IT CAN BE CONCLUDED THAT THE REPORTED CUSTOMER COMPLAINT WAS CAUSED BY PARTICULATES LODGED WITHIN THE CATHETER BELLOWS.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS. THE CHILD PATIENT (AGE AND GENDER NOT PROVIDED) UNDERWENT A CRANIOPLASTY AND THE CATHETER WAS IMPLANTED ON (B)(6) 2015. IT HAD WORKED CORRECTLY THEN. ON (B)(6) 2015, THE WAVE FORM AND "SYS/DIAS" VALUE ON THE DISPLAY SHOWED NOTHING WHEN THE HOSPITAL CHECKED THE CAM01. ONLY AVERAGE PRESSURE DISPLAYED 9 MMHG. THUS, THE CATHETER WAS EXPLANTED. THERE WAS NO REPLACEMENT CATHETER: AFTER EXPLANTING THE CATHETER, THE PRESSURE SHOWED -29. THERE WAS NO SURGERY DELAY. PATIENT OUTCOME WAS REPORTED AS "RECOVERY." ADDITIONAL INFORMATION HAS BEEN REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    669188 SUBDURAL POST CRANIOTOMY ICP MONITORING KIT N/A GWM INTEGRA NEUROSCIENCES CA/USA

    Patients

    Seq Age Sex Outcome Treatment
    1