BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 3170626 · Received June 14, 2013

    Report

    Report Number
    2024168-2013-03732
    Event Type
    Malfunction
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 2013
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    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 DEVICE WAS RETURNED FOR EVALUATION WHICH CONFIRMED THE REPORTED COMPLAINT RELATED TO THE LEAKING OF FLUID FROM THE Y-CONNECTOR. 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

    SUBSEQUENT INFORMATION RECEIVED NOTED THAT THE ARMADA 14 BALLOON DILATATION CATHETER (BDC) WAS INFLATED ONCE AND LEAKED AT THE HUB CONNECTOR. A DIFFERENT ARMADE 14 BDC WAS USED TO COMPLETE THE PROCEDURE WITHOUT REPORTED ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT USING A FEMORAL ARTERY ACCESS APPROACH DURING A PROCEDURE OF THE DORSALIS PEDIS ARTERY THE ARMADA BALLOON DILATATION CATHETER LEAKED AT THE HUB CONNECTOR. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. 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
    272079 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 803954

    Patients

    Seq Age Sex Outcome Treatment
    1