BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3874925 · Received June 16, 2014

    Report

    Report Number
    2024168-2014-03860
    Event Type
    Malfunction
    Date Received
    June 16, 2014
    Date of Event
    April 17, 2014
    Report Date
    May 22, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT YET BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE RETURNED DEVICE ANALYSIS IDENTIFIED A LEAK IN THE HUB, WHICH WAS FOUND WHEN THE BALLOON CATHETER WAS PRESSURIZED. A SEARCH OF THE COMPLAINT HANDLING DATABASE WAS PERFORMED AND NO OTHER INCIDENTS WERE IDENTIFIED FROM THIS LOT FOR HUB LEAKING ISSUES. WHILE A SEARCH OF THE LOT HISTORY RECORD FOR THIS SPECIFIC LOT INDICATED NO RELATED NON-CONFORMANCE RECORDS, BASED ON AN EXPANDED INVESTIGATION, A PRODUCT ISSUE RELATED TO LEAKAGE AT THE HUB WAS IDENTIFIED. THE EVENT WAS POSSIBLY RELATED TO HUB ASSEMBLY DURING MANUFACTURING. THESE DEVICES WILL CONTINUE TO BE MONITORED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING DEVICE PREPARATION AND PRIOR TO USE WHILE THE ARMADA 35 BALLOON DILATATION CATHETER (BDC) WAS BEING FLUSHED OUTSIDE THE ANATOMY A LEAK IN THE DISTAL PORTION BETWEEN THE GUIDE WIRE EXIT NOTCH AND THE BALLOON WAS OBSERVED. THE DEVICE WAS NOT USED IN THE ANATOMY; THERE WAS NO PATIENT INVOLVEMENT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352749 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 808538

    Patients

    Seq Age Sex Outcome Treatment
    1