BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER

    MDR report key: 3777879 · Received April 21, 2014

    Report

    Report Number
    9617494-2014-00003
    Event Type
    Death
    Date Received
    April 21, 2014
    Date of Event
    March 31, 2014
    Report Date
    April 1, 2014
    Manufacturer
    GMS - GESELLSCHAFT FUR MEDIZINISCHE SODENTECHNIK - N
    Product Code
    GWM
    PMA / PMN Number
    K040235
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE PHYSICIAN CONTACTED THE INTEGRA CLINICAL EDUCATOR REGARDING A QUESTIONABLE NONFUNCTIONING LICOX CATHETER. THE PHYSICIAN INSERTED THE LICOX IN A SEVERE TRAUMATIC BRAIN INJURY (TBI) PT ON (B)(6) 2014. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY WITH THE INITIAL INSERTION. THE NUMBER INITIALLY READ APPROXIMATELY 82 AND NEVER SETTLED DOWN. THE INTEGRA CLINICAL EDUCATOR WAS NOTIFIED BY THE PHYSICIAN ON (B)(6) 2014. THE INTEGRA CLINICAL EDUCATOR DROVE TO THE USER FACILITY TO TROUBLESHOOT. THE LICOX -MONITOR READ APPROXIMATELY 82 AND DID NOT RESPOND TO AN A OXYGEN (O2) CHALLENGE. THE PT WAS INTUBATED WITH A FRACTION OF INSPIRED OXYGEN (FIO2) AT 50% BUT WHEN INCREASED TO 100%, THE PARTIAL PRESSURE OF OXYGEN IN BRAIN TISSUE (PBTO2) DID NOT CHANGE. THE TEMPERATURE ON THE LICOX READ 37. THE PHYSICIAN DECIDED TO REPLACE THE CATHETER WITH THE ASSISTANCE OF THE INTEGRA CLINICAL EDUCATOR. IT WAS REPORTED THAT IT WENT EXTREMELY SMOOTH WITH NO DIFFICULTIES. THE PBTO2 SETTLED AFTER APPROXIMATELY 30 MINUTES TO 16.4-18.1. ADDITIONAL INFO WAS REQUESTED AND ON (B)(6) 2014, THE FOLLOWING INFO WAS PROVIDED BY THE NURSE: THE PT WAS A (B)(6) YEAR OLD MALE. THE DIFFICULTY THE PHYSICIAN ENCOUNTERED WITH THE INITIAL INSERTION OF THE LICOX CATHETER WAS THAT THE CATHETER WOULD NOT SLIDE RIGHT IN. IT WAS CONFIRMED THAT THE INITIAL CATHETER WAS EXPLANTED AND REPLACED ON (B)(6) 2014. THERE WAS NO OTHER PT HARM OR INJURY. PT OUTCOME WAS REPORTED AS "PT DIED MOST LIKELY FROM MASSIVE MI" (MYOCARDIAL INFARCTION). DATE OF DEATH OR FURTHER DETAILS REGARDING THE PT'S DEATH WAS NOT PROVIDED. HENCE, ADDITIONAL INFO/CLARIFICATION WAS REQUESTED FROM THE CUSTOMER. TO DATE, NO NEW INFO HAS BEEN RECEIVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241832 KIT CONTAINING CC1.P1 AND THE IP2 INTRODUCER LICOX BOLTS CATHETERS AND KITS GWM GMS - GESELLSCHAFT FUR MEDIZINISCHE SODENTECHNIK - N UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Death| R