BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8F TD TORQUE-LINE CATHETER

    MDR report key: 4729588 · Received April 7, 2015

    Report

    Report Number
    2025816-2015-00028
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    February 11, 2015
    Report Date
    February 26, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    FINDINGS: VISUAL ASSESSMENT OF THE "AS-RECEIVED" USED 41232-02 CATHETER DEVICE RECORDED BALLOON COMPONENT DAMAGES. THE EXACT CAUSE(S) OF THE COMPONENT DAMAGES AT THIS TIME ARE UNK.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH USE OF ONE 41232-02 8F TD CATHETER, 5 LUMEN, 110 CM, RA/RV HEPARIN COATED, LF. IT WAS REPORTED THAT ON (B)(6), "PT'S PA CATHETER BALLOON POPPED. THIS WAS NOTICED BY THE RN NEAR THE END OF HER SHIFT. THE PA CATH WAS PULLED BACK TO RA, AND EVENTUALLY PULLED OUT BY THE FELLOW." THERE WERE NO PT INJURIES AND OR ADVERSE PT CONSEQUENCES. THE CATHETER DEVICE WAS PRETESTED PRIOR TO PLACEMENT WITH NO INFLATION ISSUES OR ABNORMALITIES DETECTED AT THAT TIME. DEVICE RETURN: ONE (1) USED 41232-02 CATHETER; THREADED ON THE CATHETER WAS A UNK MFR/MODEL CONTAMINATION SHEATH. MFR'S INVESTIGATION: VISUAL ANALYSIS OF THE "AS-RECEIVED" USED 41232-02 TD CATHETER IDENTIFIED DAMAGES/TEARS TO THE CATHETER DEVICE BALLOON COMPONENT. THIS CONDITION WOULD RESULT IN BALLOON INFLATION FAILURE

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227299 8F TD TORQUE-LINE CATHETER CATHETER FPA ICU MEDICAL, INC. 41232-02 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NI UNK CONTAMINATION SHIELD