BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CATH PASSER 36CM

    MDR report key: 21664948 · Received March 21, 2025

    Report

    Report Number
    3014334038-2025-00038
    Event Type
    Injury
    Date Received
    March 21, 2025
    Date of Event
    March 3, 2025
    Report Date
    October 24, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    UDI-DI
    10381780515487
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DISPOSABLE CATHETER PASSER (821515) WAS NOT RETURNED FOR EVALUATION (AS PER CUSTOMER, PRODUCT NOT AVAILABLE) AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND DEVICE HISTORY RECORD (DHR) COULD NOT BE REVIEWED. THE ROOT CAUSE(S) OF THE REPORTED ISSUE COULD NOT BE DETERMINED, HOWEVER, A POTENTIAL ROOT CAUSE IS: USER USES AN INCOMPATIBLE/ INAPPROPRIATE TECHNIQUE OR TOOL. 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.

    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.

    Description of Event or Problem · 0

    N/A

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING THE IMPLANT PROCEDURE, WHILE TUNNELING WITH A CODMAN CATHETER PASSER (ID 347674), A VESSEL WAS NICKED AND THE PATIENT EXPERIENCED BLEEDING. THE PHYSICIAN LOCATED THE BLEED, APPLIED PRESSURE, AND LIGATED THE VESSEL TO ACHIEVE HEMOSTASIS. THIS RESOLVED THE ISSUE. ACCORDING TO INFORMATION PROVIDED, IT IS UNKNOWN IF THERE IS ANY ISSUE WITH THE CATHETER PASSER. IT IS UNKNOWN IF THERE WAS A SURGICAL DELAY DUE TO DEVICE ISSUE, OR IF THE PATIENT EXPERIENCED ANY SIGNS AND SYMPTOMS DUE TO BLOOD LOSS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    901127 DISPOSABLE CATH PASSER 36CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780515487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other