BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PARENCHYMAL PRESSIO CATHETER

    MDR report key: 6696373 · Received July 10, 2017

    Report

    Report Number
    3001587388-2017-17306
    Event Type
    Injury
    Date Received
    July 10, 2017
    Date of Event
    June 20, 2017
    Report Date
    September 14, 2017
    Manufacturer
    SOPHYSA SA
    Product Code
    GWM
    PMA / PMN Number
    K062584
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE NOT YET ANALYZED BY QUALITY CONTROL LABORATORY. INTERNAL DOCUMENTATION SHOWS THAT ICP PROBE AND ITS ACCESSORIES HAVE BEEN MANUFACTURED IN ACCORDANCE WITH QUALITY REQUIREMENTS AND NON-CLINICAL TESTING HAVE SHOWN THAT ICP BOLTS HAVE A SATISFACTORY HOLDING IN THE CRANIAL BONE. THE ANALYSIS WILL MAKE IT POSSIBLE TO KNOW THE CAUSES OF THE APPEARANCE OF THIS INCIDENT.

    Additional Manufacturer Narrative · 1

    ACCORDING TO SOPHYSA IN-HOUSE PROCESS, THE PROBE HAS BEEN ANALYZED BY QUALITY CONTROL LABORATORY. THE BOLT AND THE DRILL WERE RELATIVELY CLEAN. NO ABNORMAL DEFORMATION HAVE BEEN OBSERVED THAT COULD EXPLAINED THE HOLDING DIFFICULTY. A DIMENSIONAL ANALYSIS OF THE BOLT HAS BEEN PERFORMED AND UNABLES TO VERIFY THAT THE DRILLING KIT WERE CONFORM TO DESIGN SPECIFICATIONS. THEN, THE DRILLING ASSEMBLY WAS TESTED ACCORDING TO THE VALIDATED METHOD AND SHOWED THE DEVICE MEETING ITS DESIGN SPECIFICATION REQUIREMENTS. THE ASSIGNABLE CAUSE OF THIS EVENT COULD BE LINKED TO DIFFICULTIES IN PERFORMING THE SURGICAL PROCEDURE. OTHER INVESTIGATIONS ARE CARRIED OUT WITH THE HOSPITAL TO RESOLVE THESE DIFFICULTIES OF DRILLING. NO ADDITIONAL COMMENTS.

    Description of Event or Problem · 1

    FAILURE OF BOLT HOLDING IN CRANIAL BONE (BONE LAXITY). THE PHYSICIAN REPEATED THE OPERATION THREE TIME, INDUCING POTENTIAL INFECTIOUS RISKS.

    Description of Event or Problem · 1

    FAILURE OF BOLT HOLDING IN CRANIAL BONE (BONE LAXITY). THE PHYSICIAN REPETEAD THE OPERATION THREE TIME, INDUCING POTENTIAL INFECTIOUS RISKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    477174 PARENCHYMAL PRESSIO CATHETER ICP PRESSURE MONITORING CATHETER GWM SOPHYSA SA ICP CATHETER D0690

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention