BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CERTAS INLIN VLV SPHN/UNIT CAT

    MDR report key: 12402945 · Received August 31, 2021

    Report

    Report Number
    3013886523-2021-00377
    Event Type
    Injury
    Date Received
    August 31, 2021
    Date of Event
    August 10, 2021
    Report Date
    September 30, 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

    THE CERTAS VALVE WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND NO LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED. THE POSSIBLE ROOT CAUSE FOR THE REPORTED ¿VALVE REVERSAL SUSPECTED" COULD BE DUE TO "VALVE IS NOT SUFFICIENTLY FIXATED WHEN PLACED IN THE LUMBAR SPACE (SUTURE TABS NOT SUFFICIENTLY UTILIZED)".

    Description of Event or Problem · 0

    N/A

    Additional Manufacturer Narrative · 1

    ATTEMPTS ARE BEING MADE TO OBTAIN ADDITIONAL INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A PHYSICIAN REPORTED THAT THE CERTAS PLUS VALVE WAS IMPLANTED TO A (B)(6)-YEAR-OLD MALE PATIENT VIA L-P SHUNT ON (B)(6) 2021, WITH A SETTING OF 5. THE VALVE WAS USED WITH THE SILASCON® LUMBAR CATHETER (MANUFACTURED BY KANEKA, PRODUCT CODE: 702-JJ). THE SETTING WAS PLACED AT 5, BUT THEN A HEMATOMA APPEARED DUE TO EXCESSIVE FLOW. THE SETTING WAS IMMEDIATELY CHANGED TO 8. THE PHYSICIAN THEN TRIED CHANGING THE SETTING FROM 8 TO 7, BUT THE SET PRESSURE WAS UNABLE TO BE CHANGED. A SETTING OF 4 WAS CONFIRMED WITH THE TOOLKIT AND ETK. HOWEVER, A SETTING OF 8 WAS DISPLAYED AND CONFIRMED BY X-RAY. VALVE REVERSAL WAS SUSPECTED, AND AN UNKNOWN ADDITIONAL ACTION WAS PLANNED FOR AUGUST 12 (NO INFORMATION PROVIDED). THE PATIENT IS CURRENTLY IN FOLLOW UP. NO FURTHER INFORMATION WAS PROVIDED BY HOSPITAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289915 CERTAS INLIN VLV SPHN/UNIT CAT CERTAS PLUS W/ SG JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 91 YR SILASCON LUMBAR CATH(MANUF KANEKA, PROD: 702-JJ).| SILASCON LUMBAR CATH(MANUF KANEKA, PROD: 702-JJ).