BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV ONLY W/SPHNGD

    MDR report key: 11566525 · Received March 24, 2021

    Report

    Report Number
    3013886523-2021-00128
    Event Type
    Injury
    Date Received
    March 24, 2021
    Date of Event
    February 19, 2021
    Report Date
    May 18, 2021
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K143111
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS:  D4, D9, G3, G6, H2, H3, H4, H6, H10. THE CERTAS VALVE WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 5103379 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS - THE POSITION OF THE CAM WHEN VALVE WAS RECEIVED WAS AT SETTING 1. THE VALVE WAS VISUALLY INSPECTED; NEEDLE HOLES IN THE NEEDLE CHAMBER WERE NOTED. THE VALVE WAS HYDRATED. THE VALVE WAS LEAK TESTED AND ONLY LEAKED FROM THE NEEDLE HOLE IN THE NEEDLE CHAMBER. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION, REFLUX, SIPHON GUARD AND PRESSURE. NO ROOT CAUSE COULD BE DETERMINED AS THE TECHNICIAN COULD NOT CONFIRM ANY PROBLEM WITH THE VALVE AT THE TIME OF INVESTIGATION. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER WAS PROBABLY DUE TO BIOLOGICAL DEBRIS AND PROTEIN BUILD UP INTERFERING WITH THE VALVE MECHANISM, AT THE TIME OF INVESTIGATION NO OBSTRUCTION WAS NOTED.

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A CERTAS VALVE WAS IMPLANTED VIA VP SHUNT TO A (B)(6) PATIENT ON (B)(6) 2021. ON (B)(6), THE PHYSICIAN SUSPECTED OBSTRUCTION AND CONFIRMED IT WITH A CONTRAST MEDIUM (A LITTLE BIT OF CONTRAST FLOWING TO THE PERITONEAL SIDE). THE CONTRAST WAS PERFORMED AGAIN ON (B)(6), BUT THE CONTRAST MEDIUM WAS NOT FLOWING TO THE VALVE, SO IT WAS REMOVED AND REPLACED. A SURGICAL DELAY OF MORE THAN 30 MINUTES WAS REPORTED. BLOOD CLOTS WERE SCATTERED ON THE REMOVED VALVE. IT IS UNKNOWN IF THE PATIENT EXPERIENCED ANY SIGNS OR SYMPTOMS RELATED TO THE VALVE OBSTRUCTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    456171 CERTAS INLIN VLV ONLY W/SPHNGD CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR 5103379

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR