BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X

    MDR report key: 1005941 · Received February 22, 2008

    Report

    Report Number
    2023988-2008-00005
    Event Type
    Malfunction
    Date Received
    February 22, 2008
    Report Date
    February 22, 2008
    Manufacturer
    INTEGRA NEURO SCIENCES
    Product Code
    GWM
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE INVOLVED IN THE REPORTED INCIDENT IS NOT AVAILABLE FOR RETURN OR EVAL. AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFO.

    Description of Event or Problem · 1

    THE SURGEON REPORTED, THAT THE PROBE WAS PLACED POST CRANIOTOMY IMMEDIATELY AFTER A POST ANEURYSM SURGERY ON THE SAME SIDE AS THE CRANIOTOMY. SOME RESISTANCE TO THE PROBE UPON INSERTION WAS REPORTED BY THE SURGEON. HE REPORTED UTILIZING THE BLUE STYLET TO OPEN THE DURA. THE NS-P DIRECTIONS FOR USE (DFU) INDICATES THAT AN 18G SPINAL NEEDLE, OR EQUIVALENT, SHOULD BE USED TO OPEN THE DURA IN A CRUCIATE FASHION TO PROVIDE A 2MM OPENING. SOME OF THE RESISTANCE UPON INSERTION MAY BE ATTRIBUTED TO THE USE OF THE BLUE STYLET IN OPENING THE DURA. THE PROBE WAS INITIALLY INSERTED TO A DEPTH OF 10MM (3RD LINE MARKING ON THE CATHETER.) UPON INSERTION, THE ICP INITIALLY STARTED AT - 10MMHG, WITH A GOOD ICP WAVEFORM. AFTER SOME TIME (UNCLEAR HOW LONG BUT LIKELY MINS NOT HOURS), THE PROBE DEPTH WAS ADJUSTED TO 15MMHG (4TH LINE MARKING ON THE CATHETER). AT THAT POINT, ICP STABILIZED TO A POSITIVE VALUE THAT CORRESPONDED TO THE CLINICAL STATUS OF THE PT. THE PT HAD A SUBDURAL SUCTION DRAIN CLOSE TO THE AREA OF THE INSERTION, WHICH MAY CLINICALLY ACCOUNT FOR/CONTRIBUTE TO AN INITIAL NEGATIVE ICP READING. THE FACT THAT THE PROBE WAS PLACED IMMEDIATELY POST CRANIOTOMY MAY ALSO CLINICALLY ACCOUNT FOR CONTRIBUTE TO AN INITIAL NEGATIVE ICP READING. THE SURGEON REPORTED, THAT AT TIMES HE SEES INITIAL NEGATIVE ICP READINGS WITH ANOTHER TYPE OF ICP PROBES AS WELL. A CATSCAN OF THE PT WAS TAKEN THE NEXT DAY AFTER PLACEMENT AND INDICATED THAT THE PROBE WAS PROPERLY POSITIONED WITHIN THE PARENCHYMA. THE CEREBRAL BLOOD FLOW (CBF) PORTION OF THE PROBE DID NOT PROVIDE CBF READINGS FOR THE FIRST 2 DAYS. AFTER 2 DAYS, CBF READINGS WERE OBTAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NEUROSENSOR COMBINED ICP/CBF PARACH PROBE, 1X NEUROSENSOR GWM INTEGRA NEURO SCIENCES 305000102304

    Patients

    Seq Age Sex Outcome Treatment
    1