BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CAMINO ICP MONITORING CATHETER W/ INTEGRATED LIC

    MDR report key: 5585082 · Received April 18, 2016

    Report

    Report Number
    2023988-2016-00007
    Event Type
    Injury
    Date Received
    April 18, 2016
    Date of Event
    March 27, 2016
    Report Date
    March 28, 2016
    Manufacturer
    INTEGRA NEUROSCIENCES CA/USA
    Product Code
    GWM
    PMA / PMN Number
    K102875
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    INTEGRA HAS COMPLETED THEIR INTERNAL INVESTIGATION ON 12 MAY 2016. THE INVESTIGATION INCLUDED: THE PRODUCT WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE DEVICE HISTORY RECORDS HAS BEEN PERFORMED. THIS REVIEW CONFIRMED THAT THIS LOT OF PRODUCTS WAS REVIEWED AND RELEASED ACCORDING TO QA SPECIFICATIONS. THE DHR REVIEW HAS BEEN DEEMED SATISFACTORY. LOT WAS MFG DATE 25 AUG 2014, AND WILL BE EXP. DATE 30-NOV-2016. THE CUSTOMER REPORTED 110-4L, LOT 05000312261 THAT MISSING ONE NUMBER; IT SHOULD BE 305000312261. A REVIEW OF LOT 305000312261 INDICATES THAT IT MET ALL REQUIREMENTS BEFORE RELEASED TO FG. A REVIEW OF HISTORICAL COMPLAINT DATA DISPLAYED NO INCREASE IN TRENDS. THE NUMBER OF UNITS, MODEL 110-4XXX, (B)(4) MAR-2015 THROUGH FEB-2016 DIVIDED BY THE NUMBER OF CONFIRMED REPORTS (B)(4) AND MULTIPLIED BY 100 RESULTS IN A FAILURE RATE PERCENTAGE (B)(4). CONCLUSION: A REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY ANOMALIES OBSERVED DURING THE MANUFACTURING, PACKAGING OR INSPECTION OF THE DEVICE OR ACCESSORIES WHILE IN PROCESS. ADDITIONAL INFORMATION RECEIVED FROM THE COMPLAINANT DOES NOT ALLOW FOR CONFIRMATION OR DENIAL OF REASONABLY FORESEEABLE MISUSE OF THE CATHETER OR ACCESSORIES. ADDITIONALLY, BECAUSE THE PRODUCT WAS NOT RETURNED FOR EVALUATION, NO ROOT CAUSE COULD BE ESTABLISHED FOR THE FAILURE MODE DESCRIBED IN THE CUSTOMER COMPLAINT.

    Description of Event or Problem · 1

    THIS IS THE FIRST OF TWO REPORTS (SAME PRODUCT ID, SAME PRODUCT PROBLEM, SAME FACILITY, DIFFERENT PATIENTS). LINKED TO MFG REPORT: 2023988-2016-00008. THE DOCTOR PLACED AN IP2P LICOX CATHETER 1104L CAMINO INTRACRANIAL PRESSURE (ICP) MONITORING CATHETER ON TWO DIFFERENT PATIENTS. ON BOTH OCCASIONS WHEN THE DOCTOR TIGHTENED DOWN THE COMPRESSION CAP ON THE INTRODUCER IT WOULD MAKE THE ICP VALUE INCREASE. THE FIRST INCIDENT OCCURRED ON (B)(6) 2016. ON THIS [FIRST] PATIENT THE ICP WAS READING HIGH 30'S UP TO 60 MMHG. AS A RESULT OF THESE READINGS, THE PATIENT WAS TAKEN TO SURGERY FOR A CRANIOTOMY. THE DOCTOR PLACED A DIFFERENT MONITORING CATHETER, THE 1104B, ON THE SAME SIDE AS THE IP2P LICOX CATHETER AND POST-SURGERY THE READING WAS 5 MMHG. THE DOCTOR THEN CHECKED THE 1104L CATHETER READING AGAIN AND IT WAS STILL READING IN THE 30'S MMHG. THE 1104L CATHETER WAS REMOVED AND DISCARDED. THE DOCTOR DID NOT RECALL PULLING BACK ON THE CATHETER AFTER INSERTION SO THAT THE BLACK MARKER LINE WAS IN THE CORRECT POSITION (ON EITHER PATIENT). ADDITIONAL INFORMATION WAS REQUESTED AND IS PENDING

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    240336 CAMINO ICP MONITORING CATHETER W/ INTEGRATED LIC N/A GWM INTEGRA NEUROSCIENCES CA/USA 305000312261

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention