BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    7F TD CATHETER

    MDR report key: 4729558 · Received April 7, 2015

    Report

    Report Number
    2025816-2015-00031
    Event Type
    Malfunction
    Date Received
    April 7, 2015
    Date of Event
    February 25, 2015
    Report Date
    February 27, 2015
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S INVESTIGATION: VISUAL ANALYSIS OF THE "AS-RECEIVED" USED 41223-01 CATHETER IDENTIFIED DAMAGES/TEARS TO THE CATHETER DEVICE BALLOON COMPONENT. THIS CONDITION WOULD RESULT IN BALLOON INFLATION FAILURE. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED 41223-01 SAME LOT SAMPLE TO THE APPLICABLE PRODUCT SPECS RECORDED NO FUNCTIONAL OR OUT OF SPEC CONDITIONS. FOLLOW UP INFO REPORTED THAT A SIZE 7FR 407847 ST. JUDE ULTIMUM SHEATH WAS USED. THE 41223-01 7FR TD CATHETER DFU STATES/IDENTIFIES THAT A 8F OR LARGER SIZED ANCILLARY DEVICES (INTRODUCERS/SHEATHS) SHOULD BE USED. THE DFU TABLE ALSO IDENTIFIES THE DIAMETER OF THE DEFLATED BALLOON MEASURES 8F. MFG LOT BUILD RECORD REVIEW: A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED LOT# 46-847-HE (MFG (B)(6) 2014) SHOWED (B)(4) UNITS WERE MANUFACTURED, TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: VISUAL ASSESSMENT OF THE "AS-RECEIVED" USED 41223-01 CATHETER DEVICE RECORDED BALLOON COMPONENT DAMAGES. ENGINEERING TESTING AND ANALYSIS OF THE RETURNED PACKAGED SAME LOT SAMPLE RECORDED NO PERFORMANCE ISSUES/OUT OF SPEC CONDITIONS. THE MOST LIKELY CAUSE(S) OF THE 41223-01 BALLOON COMPONENT DAMAGES WERE DUE TO USAGE ERROR/INCORRECT SIZED SHEATH.

    Description of Event or Problem · 1

    COMPLAINT RECEIVED REPORTING BALLOON INFLATION FAILURE WITH USE OF ONE (1) 41223-01 TD CATHETER, 7F, 4 LUMEN, 110 CM. THE INITIAL INFO RECEIVED REPORTS THAT ON (B)(6), "...THE BALLOON ON THE CATHETER TIP RUPTURED .... THE BALLOON WAS TESTED PRIOR TO INSERTION AFTER IT PASSED THROUGH THE 7 FR ST. JUDE ULTIMUM SHEATH SHEATH) AND GUIDELINES FOR INFLATION CAPACITY WERE FOLLOWED. AFTER THE BALLOON RUPTURED THE CATHETER WAS REMOVED AND MULTIPLE VENEGRAMS WERE SHOT BUT NO BALLOON PARTICLES WERE DISCOVERED INSIDE THE PT." THERE WERE NO REPORTED PT INJURIES, ADVERSE OUTCOMES. DEVICE RETURN: ONE (1) USED 1223-01 CATHETER AND ONE PACKAGED 41223-01, LOT#46-847-HE SAME LOT SAMPLE CATHETER WERE RETURNED. THE CATHETER SHEATH WAS NOT RETURNED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    227165 7F TD CATHETER CATHETER FPA ICU MEDICAL, INC. 41223-01 46-847-HE

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR 7 FR ST. JUDE ULTIMUM SHEATH