BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 3770861 · Received April 24, 2014

    Report

    Report Number
    2024168-2014-02556
    Event Type
    Malfunction
    Date Received
    April 24, 2014
    Date of Event
    March 6, 2014
    Report Date
    March 31, 2014
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) - USE AFTER DAMAGE. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. 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. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. THESE DEVICES WILL CONTINUE TO BE MONITORED. IT SHOULD BE NOTED THAT THE ARMADA 35 INSTRUCTION FOR USE (IFU) STATES: CAREFULLY INSPECT THE CATHETER PRIOR TO USE TO VERIFY THAT IT HAS NOT BEEN DAMAGED DURING SHIPMENT AND THAT ITS SIZE, SHAPE AND CONDITION ARE SUITABLE FOR THE PROCEDURE FOR WHICH IT IS TO BE USED. IN THIS CASE, USING THE DEVICE DOES NOT APPEAR TO HAVE CONTRIBUTED TO THE DIFFICULTY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE ARMADA 35 6MM/80MM ON 135CM BALLOON CATHETER WOULD NOT HOLD PRESSURE DURING INFLATION. A LEAK WAS OBSERVED AT THE HUB OF THE DEVICE; HOWEVER, WHILE HOLDING THE SHAFT BY THE HUB STRAIGHT, INFLATION WAS ABLE TO BE SUCCESSFULLY PERFORMED. NO OTHER DEVICE WAS NEEDED. NO ADVERSE PATIENT EFFECTS OR CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    248947 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 30304G1

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR