BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3182120 · Received June 21, 2013

    Report

    Report Number
    2024168-2013-03850
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Date of Event
    May 28, 2013
    Report Date
    May 29, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 CONFIRMED THE REPORTED LEAK AT THE HUB WHEN A PROXY INDEFLATOR FILLED WITH WATER WAS USED TO PRESSURIZE THE BALLOON CATHETER. THE ROOT CAUSE OF THE HUB LEAKAGE WAS IDENTIFIED AS A COMBINATION OF SHRINKAGE OF THE ADHESIVE MATERIAL DURING THE BONDING PROCESS AND THE ANNULAR SPACE AVAILABILITY. 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. FURTHER ASSESSMENT OF THIS ISSUE PER SITE OPERATING PROCEDURES WAS PERFORMED. AS AN IMMEDIATE CORRECTIVE ACTION, AN ADDITIONAL INSPECTION WAS IMPLEMENTED IN THE MANUFACTURING PROCESS. WHILE ABBOTT VASCULAR IS CONTINUING TO EVALUATE AN ALTERNATIVE ADHESIVE MATERIAL TO FURTHER MITIGATE THE OCCURRENCE OF THE REPORTED ISSUE, THE OVERALL RISK REMAINS LOW WITH NO REPORTED PATIENT EFFECTS, CONSISTENT WITH THE PRODUCT RISK ASSESSMENT DOCUMENTATION. THE ADHESIVE SELECTION, PROCESS DEVELOPMENT, VALIDATION, SHELF LIFE STUDIES, AND REGULATORY APPROVALS ARE EXPECTED TO BE COMPLETED OVER THE COMING QUARTERS TO DETERMINE IF A NEW ADHESIVE SUCCESSFULLY MITIGATES THE OCCURRENCE RATE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT WHEN PREPPING THE 2.5 MM X 200 MM X 150 CM ARMADA BALLOON CATHETER, CONTINUOUS BUBBLES WERE OBSERVED AND IT WAS SUSPECTED THAT THERE WAS A HOLE IN THE BALLOON. THE BALLOON CATHETER WAS NOT USED ON THE PATIENT. THERE WAS NO CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    281954 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 811872

    Patients

    Seq Age Sex Outcome Treatment
    1