BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BACTISEAL PERITONEAL CATHETER

    MDR report key: 20274612 · Received September 20, 2024

    Report

    Report Number
    3013886523-2024-00292
    Event Type
    Injury
    Date Received
    September 20, 2024
    Date of Event
    July 29, 2024
    Report Date
    December 17, 2024
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K102589
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    THE BACTISEAL PERITONEAL CATHETER (ID 823074) WAS NOT RETURNED FOR EVALUATION; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED. LOT NUMBER INFORMATION HAS BEEN PROVIDED; THEREFORE, DEVICE HISTORY RECORD (DHR) WAS REVIEWED, AND NO ANOMALIES WERE FOUND. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, THE POSSIBLE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER COULD BE DUE TO USER¿S ERROR, POSSIBLE WHEN CONNECTING THE CATHETERS. 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.

    Description of Event or Problem · 0

    THIS IS 4 OF 7 REPORTS LINKED TO MFG REPORT NUMBERS: 3013886523-2024-00288, 3013886523-2024-00289, 3013886523-2024-00290, 3013886523-2024-00296, 3013886523-2024-00297, 3013886523-2024-00298. A PATIENT REPORTED A VALVE (UNKNOWN ID), VENTRICULAR CATHETER (UNKNOWN ID) AND A PERITONEAL CATHETER (UNKNOWN ID) WAS IMPLANTED ON (B)(6) 1997. IN (B)(6) 2024, THE PATIENT HAD INDICATION OF FAILING VALVE AND CATHETERS. THE PATIENT UNDERWENT 6 REVISIONS, 5 OF WHICH WERE CAUSED BY HIS BODY REJECTING THE CATHETER AND IT WAS DRAINING CEREBROSPINAL FLUID (CSF) OUTSIDE THE CAVITY AND UNDER THE SKIN WHERE IT COULD NOT BE ABSORBED. REVISIONS: #1 - ON (B)(6) 2024: OLD VALVE AND VENTRICULAR CATHETER WERE REPLACED WITH A CODMAN VALVE (UNKNOWN ID) AND BACTISEAL PERITONEAL CATHETER (ID 823074). #2 - ON (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND WAS REPOSITIONED. #3 - ON (B)(6) 2024: OLD VENTRICULAR CATHETER WAS REPLACED. #4 - ON (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND WAS REPOSITIONED. #5 - ON (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PERITONEAL CAVITY AND REINSERTED INTO THE PLEURAL CAVITY. #6 - ON (B)(6) 2024: CATHETER WAS EXPELLED FROM THE PLEURAL CAVITY THEREFORE, IT WAS REMOVED. VALVE WAS CAPPED AND AN ETV (ENDOSCOPIC THIRD VENTRICULOSTOMY) PROCEDURE WAS PERFORMED. THE PATIENT TESTED POSITIVE FOR ALLERGY TO CLINDAMYCIN. NOTE FROM MANUFACTURER: THIS REPORT IS FOR REVISION #6.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1553696 BACTISEAL PERITONEAL CATHETER BACTISEAL PERITONEAL CATHETER JXG INTEGRA LIFESCIENCES MANSFIELD M8789400A001

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Required Intervention VALVE