BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 5525200 · Received March 24, 2016

    Report

    Report Number
    2024168-2016-01933
    Event Type
    Malfunction
    Date Received
    March 24, 2016
    Date of Event
    February 17, 2016
    Report Date
    March 24, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    PMA / PMN Number
    K102705
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION SUMMARY: THE DEVICE WAS RETURNED FOR ANALYSIS. THE BUNCHING WAS CONFIRMED. ADDITIONALLY, THE BALLOON WAS PRESSURIZED AND FLUID LEAKED FROM A PINHOLE. THE RESISTANCE WAS UNABLE TO BE CONFIRMED AS IT WAS BASED ON CASE CIRCUMSTANCES. BASED ON A VISUAL ANALYSIS OF THE RETURNED DEVICE, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE INVESTIGATION DETERMINED THAT THE REPORTED DIFFICULTIES APPEAR TO BE RELATED TO CASE CIRCUMSTANCES. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. ADDITIONALLY, A REVIEW OF THE COMPLAINT HISTORY IDENTIFIED NO OTHER INCIDENTS FROM THIS LOT. BASED ON THE INFORMATION REVIEWED, THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING. THE ARMADA 14 DEVICE WAS FILED UNDER MEDWATCH #2024168-2016-01549.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ANTERIOR TIBIAL ARTERY USING THE ANTIGRADE LEFT GROIN AN ARMADA BALLOON (LOT 5112441) WAS ADVANCED WITH SOME ANATOMICAL RESISTANCE AND TIP BUNCHING, BUT WAS SUCCESSFULLY USED IN THE PROCEDURE AND REMOVED WITHOUT ISSUE. A DIFFERENT 2.0 X 200 MM ARMADA BALLOON (LOT 5112541) MET ANATOMICAL RESISTANCE DURING ADVANCING AND AFTER DEFLATION REMOVAL WAS DIFFICULT, RESULTING IN THE SHAFT SEPARATION. THE ARMADA SHAFT WAS REMOVED SUCCESSFULLY ON THE GUIDE WIRE FROM THE ANATOMY. AN ARMADA 18 BALLOON WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORTED ADVERSE PATIENT EFFECT. THERE WAS NO REPORTED CLINICALLY SIGNIFICANT DELAY IN THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURN DEVICE ANALYSIS REVEALED A PINHOLE RUPTURE IN THE BALLOON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    178441 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 5112441

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR