BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3103114 · Received May 9, 2013

    Report

    Report Number
    2024168-2013-02911
    Event Type
    Malfunction
    Date Received
    May 9, 2013
    Date of Event
    April 12, 2013
    Report Date
    April 15, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS NOT RETURNED. A REVIEW OF THE COMPLAINT HANDLING DATABASE FOR THIS LOT REVEALED ONE SIMILAR INCIDENT. AN EXPANDED RECORDS REVIEW CONFIRMED THIS ISSUE TO BE RELATED TO HUMAN ERROR BY A SINGLE OPERATOR DURING THE MANUFACTURING PROCESS. CORRECTIVE ACTION WAS IMPLEMENTED TO PREVENT RECURRENCE. THE BALLOON PACKAGING WAS CORRECTLY LABELED AS A 2.0MMX 40MMX150 BUT THE IDENTITY ON THE HUB WAS LABELED AS 2.5MMX200MM. THE BALLOON WAS SELECTED BASED ON THE PACKAGE LABELING (WHICH ACCURATELY REFLECTED THE BALLOON SIZE). THE PROCEDURE WAS PERFORMED SUCCESSFULLY, WITH NO ADVERSE PATIENT EFFECTS. ALTHOUGH THE LABELING ISSUE MAY CAUSE CUSTOMER DISSATISFACTION, IT WOULDN'T RESULT IN PATIENT HARM.

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER REPORTED THE DEVICE WAS DISCARDED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING THE PROCEDURE IN AN UNSPECIFIED DISTAL MEMBER, DILATATION WAS PERFORMED USING AN ARMADA 14 DILATATION CATHETER. THE CATHETER WAS WITHDRAWN FROM THE ANATOMY AND PUT IN A TRAY WITH SALINE. WHEN THE PHYSICIAN WAS READY TO USE THE CATHETER AGAIN, THE PHYSICIAN NOTED THAT THERE WAS A LABELING MISMATCH FROM THE LABELED SIZE ON THE BOX (2.0X40X150) AND THE LUER CONNECTOR (2.5X200). DILATATION WAS COMPLETED USING THE SAME DEVICE WITHOUT CONSEQUENCE. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE DUE TO THE DEVICE ISSUE. THE PHYSICIAN INTENDED TO USE A 2.0X40X150 ARMADA 14. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    203015 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 793168

    Patients

    Seq Age Sex Outcome Treatment
    1