BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DISPOSABLE CATH PASSER 36CM

    MDR report key: 22283718 · Received June 18, 2025

    Report

    Report Number
    3014334038-2025-00082
    Event Type
    Injury
    Date Received
    June 18, 2025
    Date of Event
    May 19, 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

    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

    UPDATED FIELDS: D4, D9, G3, G6, H2, H3, H6, H11. THE DISPOSABLE CATHETER PASSER (ID 821515) WAS NOT RETURNED FOR EVALUATION AFTER THREE GOOD FAITH ATTEMPTS (GFES) WERE MADE. 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.

    Description of Event or Problem · 0

    A PHYSICIAN REPORTED THAT DURING THE IMPLANTATION PROCEDURE, WHILE TUNNELING WITH A DISPOSABLE CATHETER PASSER (ID 821515), A VESSEL WAS INADVERTENTLY NICKED AND THE PATIENT EXPERIENCED BLEEDING. THE SURGEON MADE ANOTHER INCISION TO LOCATE THE SOURCE, APPLIED DIRECT PRESSURE, AND CAUTERY WAS USED 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.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    853223 DISPOSABLE CATH PASSER 36CM SHUNT,NERVOUS SYSTEM & COMPS JXG INTEGRA LIFESCIENCES MANSFIELD 10381780515487

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other INSPIRE STIMULATION LEAD MODEL# 4063SI