BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CATH PASSER 36CM

    MDR report key: 20325982 · Received September 27, 2024

    Report

    Report Number
    3014334038-2024-00197
    Event Type
    Injury
    Date Received
    September 27, 2024
    Date of Event
    August 23, 2024
    Report Date
    February 14, 2025
    Manufacturer
    INTEGRA LIFESCIENCES MANSFIELD
    Product Code
    JXG
    PMA / PMN Number
    K944222
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: D9, G3, G6, H2, H3, H6, H11. THE DISPOSABLE CATHETER PASSER (ID (B)(4)) WAS NOT RETURNED FOR EVALUATION 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 CAUSE OF THE REPORTED EVENT MAY BE RELATED TO EXCESS PRESSURE APPLICATION DURING THE PROCEDURE. 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 FACILITY REPORTED A CATHETER PASSER (ID 821515) NICKED THE ANTERIOR JUGULAR VEIN WHILE TUNNELING DURING THE IMPLANTATION PROCEDURE. THE PHYSICIAN APPLIED PRESSURE AND USED CAUTERY TO STOP THE BLEEDING, AND 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
    1739864 DISPOSABLE CATH PASSER 36CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other