BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PROG VALVE CLYNDRICAL W PRECHA

    MDR report key: 10280095 · Received July 15, 2020

    Report

    Report Number
    1226348-2020-00193
    Event Type
    Injury
    Date Received
    July 15, 2020
    Date of Event
    March 25, 2020
    Report Date
    March 26, 2020
    Manufacturer
    INTEGRA LIFESCIENCES SWITZERLAND SAR
    Product Code
    JXG
    PMA / PMN Number
    K122118
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: UNIQUE DEVICE IDENTIFIER (UDI): (B)(4). SAMPLE WAS RECEIVED FOR EVALUATION. DEVICE HISTORY RECORD (DHR) - LOT 3240360 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS- THE VALVE WAS VISUALLY INSPECTED; BIOLOGICAL DEBRIS WAS NOTED AS WELL AS A SMALL CUT/TEAR IN THE SILICONE HOUSING NEAR THE DISTAL CONNECTOR. THE VALVE PASSED THE TEST FOR PROGRAMMING, OCCLUSION AND PRESSURE. THE VALVE WAS LEAK TESTED, IT LEAKED FROM THE CUT/TEAR NEAR THE DISTAL CONNECTOR. THE VALVE COULD NOT BE REFLUX TESTED DUE TO THE DAMAGED SILICONE HOUSING. THE ROOT CAUSE FOR THE CUT/TEAR IN THE SILICONE HOUSING IS PROBABLY DUE TO USER ERROR, AS NOTED IN THE INSTRUCTIONS FOR USE (IFU) SILICONE HAS A LOW CUT/TEAR RESISTANCE. THE POSSIBLE ROOT CAUSE FOR THE PROBLEMS REPORTED BY THE CUSTOMER COULD HAVE BEEN DUE TO BIOLOGICAL DEBRIS INTERFERING WITH THE VALVE, NO PROGRAMMING OR OCCLUSION ISSUES WERE NOTED DURING THE INVESTIGATION. BETWEEN 05NOV2019 AND 30JUN2020, APPROXIMATELY 2,200 MDRS SUBMITTED ELECTRONICALLY BY INTEGRA LIFESCIENCES VIA TRACKWISE, INTEGRA'S COMPLAINT HANDLING SYSTEM, WERE NOT RECEIVED BY CDRH DUE TO A COMPUTER SYSTEM ISSUE. WITHIN THIS TIME PERIOD, AN ERROR WITH INTEGRA'S MIDDLEWARE, WHICH FACILITATES COMMUNICATIONS BETWEEN TRACKWISE AND THE FDA SYSTEM, CAUSED THE COMPLAINT RECORDS TO CLOSE AND INDICATE WE HAD RECEIVED AN ACKNOWLEDGEMENT 3 FROM THE FDA WHEN WE HAD NOT. INTEGRA INTERPRETED THE ACKNOWLEDGEMENT AS A SUCCESSFUL SUBMISSION; HOWEVER, SUBSEQUENT INVESTIGATION REVEALED THE ACKNOWLEDGEMENT 3 RECEIVED WAS FROM OUR MIDDLEWARE AND NOT FROM THE FDA (THESE ACKNOWLEDGEMENTS HAVE BEEN RETAINED AS PART OF THE DOCUMENTATION OF THE MDR). THE MALFUNCTION WAS RELATED TO THE RELOCATION OF THE TRACKWISE APPLICATION TO A NEW DATA CENTER DURING THE TRANSITION OF INTEGRA'S CORPORATE HEADQUARTERS FROM PLAINSBORO, NJ TO PRINCETON, NJ. PREVIOUSLY, INTEGRA HAD BEEN SUCCESSFULLY RECEIVING ACKNOWLEDGEMENTS 1, 2, AND 3 FROM THE FDA, AND OUR RECORDS REFLECT THESE ACKNOWLEDGEMENTS, INCLUDING THE DATE AND TIME STAMPS. CAPA PR 229048 AND NC 20-011 HAVE BEEN OPENED BY INTEGRA TO FURTHER INVESTIGATE THE NONCONFORMANCE AND DEVELOP A CORRECTIVE ACTION PLAN. THE MIDDLEWARE ERROR HAS BEEN CORRECTED, AND INTEGRA HAS FILED MDRS SINCE THE CORRECTION AND VERIFIED THAT THE APPROPRIATE ACKNOWLEDGEMENTS HAVE BEEN RECEIVED FROM THE FDA. INTEGRA IS RESUBMITTING ALL IMPACTED MDR REPORTS FOR THE TIME PERIOD 05NOV2019 THROUGH 30JUN2020. INTEGRA LIFESCIENCES CONTACTED (B)(6) , DIRECTOR OF REGULATORY PROGRAMS, OFFICE OF PRODUCT EVALUATION AND QUALITY AND (B)(6) , ASSISTANT DIRECTOR, MDR TEAM, OFFICE OF PRODUCT EVALUATION AND QUALITY ON JULY 8-9, 2020 TO REPORT THESE ISSUES REGARDING MDR REPORTS.

    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 NO FLOW FROM THE HAKIM VALVE AND UNABLE TO CHANGE THE SETTING. THE VALVE WAS IMPLANTED VIA V-P SHUNT DUE TO HYDROCEPHALUS AFTER CEREBRAL HEMORRHAGE ON (B)(6) 2019. THE VALVE WAS USED WITH BACTISEAL CATHETER (823072). AN INITIAL SETTING WAS UNKNOWN. ON (B)(6) 2020, THE PATIENT PRESENTED HYDROCEPHALUS SYMPTOMS AND SOMNOLENCE, CSF WAS CHECKED BUT NO ANOMALY WAS FOUND IN THE CSF. THEN, THE CONTRAST TEST WAS PERFORMED, IT APPEARED THAT NO FLOW WAS CONFIRMED FROM THE VALVE CAM. ALSO, IT WAS UNABLE TO CHANGE THE SETTING WHEN ATTEMPTED. THEREFORE, IT WAS REPLACED WITH A NEW VALVE ON (B)(6) 2020. THE PHYSICIAN COMMENTED THAT BLOOD WAS MIXED INTO THE VALVE AT THE TIME OF EXPLANT. NO BLOOD WAS OBSERVED DURING THE IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742274 PROG VALVE CLYNDRICAL W PRECHA CHPV JXG INTEGRA LIFESCIENCES SWITZERLAND SAR

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR