BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 35 PTA CATHETER

    MDR report key: 14595436 · Received June 3, 2022

    Report

    Report Number
    2024168-2022-05950
    Event Type
    Malfunction
    Date Received
    June 3, 2022
    Date of Event
    May 2, 2022
    Report Date
    August 30, 2022
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    LIT
    UDI-DI
    08717648154485
    PMA / PMN Number
    K111899
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

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

    Additional Manufacturer Narrative · 0

    VISUAL, FUNCTIONAL AND SCANNING ELECTRON MICROSCOPY (SEM) INSPECTIONS/ANALYSIS WERE PERFORMED ON THE RETURNED DEVICE. THE BALLOON WAS ULTIMATELY SENT TO THE SEM LAB FOR FURTHER ANALYSIS. THE SEM REPORT DETERMINED THE SAMPLE LEAK MAY BE ATTRIBUTED TO MECHANICAL DAMAGE BETWEEN THE INFLATION AND GUIDEWIRE LUMENS AT THE SLIT SIDE OF THE SHAFT. THE ENTIRE LENGTH OF THE SAMPLE WAS INSPECTED FOR EVIDENCE OF LEAKS. A SUSPECT AREA WAS FOUND IN THE INFLATION LUMEN AT THE SIDE LEG PORT. DURING SEM INSPECTION A LEAK WAS FOUND AT THE SUSPECT AREA. SLIGHT DAMAGE AND TEARING WERE DOCUMENTED AT THE LEAK EDGES. THE REPORTED LEAK WAS CONFIRMED. A REVIEW OF THE LOT HISTORY RECORD REVEALED NO MANUFACTURING NONCONFORMITIES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER SIMILAR INCIDENTS AND/OR COMPLAINTS FROM THIS LOT. THE INVESTIGATION DETERMINED A POTENTIAL PRODUCT QUALITY ISSUE BASED ON THE REPORTED AND CONFIRMED LEAK DURING RETURN ANALYSIS. THE ISSUE IS BEING ADDRESSED PER INTERNAL OPERATING PROCEDURES. ABBOTT VASCULAR WILL CONTINUE TO TREND THE PERFORMANCE OF THESE DEVICES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREPARATION OF THE 3.0X20MM ARMADA 35 BALLOON DILATATION CATHETER, AIR ASPIRATION COULD NOT BE COMPLETED. THE DEVICE WAS NOT USED. ANOTHER UNSPECIFIED DEVICE WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT AND NO CLINICALLY SIGNIFICANT DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1557093 ARMADA 35 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT ABBOTT VASCULAR B1030-020 10716G1 08717648154485

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown