BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM

    MDR report key: 21717836 · Received March 28, 2025

    Report

    Report Number
    3003637635-2025-00007
    Event Type
    Malfunction
    Date Received
    March 28, 2025
    Date of Event
    February 26, 2025
    Report Date
    April 30, 2025
    Manufacturer
    CONTRACT MEDICAL INTERNATIONAL GMBH
    Product Code
    DYB
    UDI-DI
    04251244502317
    PMA / PMN Number
    K221914
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE ROOT CAUSE OF THE INCIDENT IS UNKNOWN AT TIME OF THE INTITIAL REPORT. THE COMPLAINT DEVICE WILL NOT BE RETURNED FOR AN EVALUATION. THE DHR REVIEW WHICH EXAMES THE DHR, NCRS, AND ECOS WILL BE DONE AS PART OF THE ROOT CAUSE INVESTIGATION.

    Additional Manufacturer Narrative · 0

    INITIAL REPORT SUBMITTED ON 28 MARCH 2025, PER MFR #: 3003637635-2025-00007. THE COMPLAINT DEVICES WAS NOT RETURNED. THEREFORE TESTING OF THE ACTUAL DEVICE IN THE REPORTED ADVERSE EVENT IS NOT POSSIBLE. THE DHR/BATCH RECORD REVIEW SHOWED THAT THERE IS NO PRODUCTION OR DESIGN ISSUE THAT CAN LEAD TO THE DEFECT WHICH CAUSED THE COMPLAINT CASE. THERE IS NO PROCESS RELATED ROOT CAUSE FOUND FROM DHR REVIEW. ROOT CAUSE IS ESTABLISHED AS UNDETERMINABLE.

    Description of Event or Problem · 0

    THE PROBLEM WAS DESCRIBED AS: "THE HUB ON THE 8X60 CATAPULT COMES OFF DURING PROCEDURE CAUSING LEAKING, THIS HAPPENED ON TWO IN A ROW". AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS. DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,PROCEDURE - NO INFORMATION AVAILABLE PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT. RETURNED PRODUCT EXPECTED: NO.

    Description of Event or Problem · 0

    THE PROBLEM WAS DESCRIBED AS: "THE HUB ON THE 8X60 CATAPULT COMES OFF DURING PROCEDURE CAUSING LEAKING, THIS HAPPENED ON TWO IN A ROW". AS REPORTED DEVICE CODES: 1188: DETACHMENT OF DEVICE OR DEVICE COMPONENT AS REPORTED PATIENT CODES: 9398: NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS DEVICE/PROCEDURE OUTCOME: UNABLE TO USE DEVICE - ATTEMPTED,PROCEDURE - NO INFORMATION AVAILABLE PATIENT OUTCOME: F26: NO HEALTH CONSEQUENCES OR IMPACT RETURNED PRODUCT EXPECTED: NO . ON 10.03.2025 ADDITIONAL DETAIL IS REQUESTED ON POWER INJECTOR USAGE AND LOT NUMBER. CUSTOMER PROVIDED BELOW ANSWER ON THE SAME DAY. "RESPONSE FROM CUSTOMER: "THEY OPENED ANOTHER CATAPULT SHEATH, ALL THE DETAILS I PUT IN THE ORIGINAL COMPLAINT ARE ALL I HAVE, I APOLOGIZE." A SHIP HISTORY WAS PERFORMED AND IDENTIFIED BATCH 800427. PLEASE PERFORM YOUR DHR USING THAT BATCH NUMBER."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1437028 CATAPULT, HYDROPHILLIC COATED INTRODUCER SHEATH SYSTEM, 8F, 60CM INTRODUCER SHEATH DYB CONTRACT MEDICAL INTERNATIONAL GMBH FG-38060-001 800427 04251244502317

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other