BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TEMPO

    MDR report key: 20279813 · Received September 23, 2024

    Report

    Report Number
    9616099-2024-00310
    Event Type
    Malfunction
    Date Received
    September 23, 2024
    Date of Event
    August 24, 2024
    Report Date
    October 15, 2024
    Manufacturer
    CORDIS US. CORP
    Product Code
    DQO
    UDI-DI
    10705032008358
    PMA / PMN Number
    K973401
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION IS PENDING AND WILL BE SUBMITTED WITHIN 30 DAYS UPON RECEIPT.

    Additional Manufacturer Narrative · 0

    AS REPORTED, THE FIRST TIME THE 5F 125CM TEMPO MP A1 CONTRAST CATHETER WENT TOWARDS THE BLOOD VESSEL; AFTER REMOVING IT, THE OPERATOR WIPED THE BLOOD ON THE TUBE WITH GAUZE, AND THE TIP END OF THE TUBE BROKE OFF WITH A GENTLE RUBBING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE VESSEL HAD NO TORTUOSITY, AND THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WAS NOT RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS. DEVICE IMAGES SHOWING THE SEPARATED TIP ARE NOT AVAILABLE. WITHOUT THE RETURN OF THE DEVICE OR IMAGES FOR ANALYSIS, THE REPORTED CUSTOMER EVENT ¿BRITE TIP/DISTAL TIP-SEPARATED¿ COULD NOT BE CONFIRMED. HANDLING OR PROCEDURAL 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 TO THE CATHETER TIP DURING REMOVAL FROM THE PACKAGE, GRASP THE HUB AND WITHDRAW THE CATHETER.¿ BASED ON THE AVAILABLE INFORMATION, THERE IS NO INDICATION THAT THE EVENT IS RELATED TO THE DEVICE DESIGN OR MANUFACTURING PROCESS. THEREFORE, NO PREVENTATIVE OR CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 0

    AS REPORTED, THE FIRST TIME THE 5F 125CM TEMPS MP A1 CONTRAST CATHETER WENT TOWARDS THE BLOOD VESSEL, AFTER REMOVING IT, THE OPERATOR WIPED THE BLOOD ON THE TUBE WITH GAUZE, AND THE TIP END OF THE TUBE BROKE OFF WITH A GENTLE RUBBING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE VESSEL HAD NO TORTUOSITY, AND THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL BE RETURNED FOR EVALUATION. DEVICE IMAGES SHOWING THE TIP BROKEN OFF ARE NOT AVAILABLE.

    Description of Event or Problem · 0

    AS REPORTED, THE FIRST TIME THE 5F 125CM TEMPO MP A1 CONTRAST CATHETER WENT TOWARDS THE BLOOD VESSEL, AFTER REMOVING IT, THE OPERATOR WIPED THE BLOOD ON THE TUBE WITH GAUZE, AND THE TIP END OF THE TUBE BROKE OFF WITH A GENTLE RUBBING. THERE WAS NO REPORTED INJURY TO THE PATIENT. THE DEVICE WAS PREPARED AS SPECIFIED BY THE INSTRUCTIONS FOR USE (IFU). THERE WAS NO APPARENT DAMAGE TO THE DEVICE NOTICED PRIOR TO USE. THE VESSEL HAD NO TORTUOSITY, AND THERE WAS NO RESISTANCE ENCOUNTERED WHILE ADVANCING OVER THE GUIDEWIRE. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION AS MULTIPLE ATTEMPTS WERE MADE WITHOUT SUCCESS. DEVICE IMAGES SHOWING THE TIP BROKEN OFF ARE NOT AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1430613 TEMPO CATHETER, INTRAVASCULAR, DIAGNOSTIC DQO CORDIS US. CORP 18290488 10705032008358

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male THE TERUMO 8F FEMORAL SHEATH.