BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CATHETER EXTENSION

    MDR report key: 20125283 · Received September 3, 2024

    Report

    Report Number
    9616099-2024-00289
    Event Type
    Malfunction
    Date Received
    September 3, 2024
    Date of Event
    August 6, 2024
    Report Date
    September 27, 2024
    Manufacturer
    CORDIS US CORP
    Product Code
    DQO
    UDI-DI
    10705032064712
    PMA / PMN Number
    K970854
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    DURING AORTOGRAM PROCEDURES IN HEMODYNAMIC LABORATORIES, WHEN USING THE 65 CM CATHETER EXTENSION TUBING FOR THE INJECTOR, IT DID NOT WORK PROPERLY, CAUSING A LEAK OF CONTRAST MEDIUM, WHEN CONNECTING IT TO THE INJECTOR AND STARTING TO INJECT. THIS REQUIRED THE USE OF A SECOND DEVICE THAT HAD THE SAME FAULT. THE SITUATION WAS CORRECTED BY USING A THIRD DEVICE, WHICH WORKED CORRECTLY, WITHOUT CAUSING ANY HARM TO THE PATIENT. THERE WAS NO DEVICE DAMAGE NOTED. THE DEVICES WERE NOT RETURNED FOR EVALUATION AS ANTICIPATED. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿CATHETER EXTENSION TUBING-LEAKAGE¿ COULD NOT BE CONFIRMED FOR EITHER DEVICE. SHIPPING/HANDLING FACTORS MAY HAVE CONTRIBUTED TO THE REPORTED EVENT. USERS ARE TRAINED TO INSPECT FOR SIGNS OF DAMAGE PRIOR TO AND DURING USE. ANY PRODUCT WITH DAMAGE IS NOT TO BE USED. INFORMATION FOR SAFETY IS PROVIDED IN THE PRODUCTS LABELING WITH THE INTENT TO MAKE THE USER AWARE OF THE RISKS. ACCORDING TO THE INSTRUCTIONS FOR USE (IFU), ALTHOUGH NOT INTENDED AS A MITIGATION OF RISK, ¿TO PREVENT DAMAGE, WITHDRAW THE CATHETER EXTENSION GENTLY. RAPID REMOVAL OR JERKING MAY DAMAGE THE EXTENSION.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS AVAILABLE FOR ANALYSIS BUT HAS NOT YET BEEN RECEIVED. ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Description of Event or Problem · 0

    THE DEVICES WERE NOT RETURNED FOR EVALUATION AS ANTICIPATED.

    Description of Event or Problem · 0

    DURING AORTOGRAM PROCEDURES IN (B)(6) LABORATORIES, WHEN USING THE 65 CM CATHETER EXTENSION TUBING FOR THE INJECTOR, IT DID NOT WORK PROPERLY, CAUSING A LEAK OF CONTRAST MEDIUM, WHEN CONNECTING IT TO THE INJECTOR AND STARTING TO INJECT. THIS REQUIRED THE USE OF A SECOND DEVICE THAT HAD THE SAME FAULT. THE SITUATION WAS CORRECTED BY USING A THIRD DEVICE, WHICH WORKED CORRECTLY, WITHOUT CAUSING ANY HARM TO THE PATIENT. THERE WAS NO DEVICE DAMAGE NOTED. THE DEVICES ARE EXPECTED TO BE RETURNED FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1105934 CATHETER EXTENSION CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US CORP 18266536 10705032064712

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown