BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 5496086 · Received March 11, 2016

    Report

    Report Number
    2024168-2016-01549
    Event Type
    Malfunction
    Date Received
    March 11, 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 AND THE SEPARATION WAS CONFIRMED. THE RESISTANCE WAS UNABLE TO BE CONFIRMED DUE TO THE CONDITION OF THE RETURNED DEVICE. 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 OTHER ARMADA DEVICE (LOT 5112441) IS FILED UNDER A SEPARATE MEDWATCH MANUFACTURER REPORT REFERENCE NUMBER.

    Additional Manufacturer Narrative · 1

    (B)(4). DURING PROCESSING OF THIS COMPLAINT, ATTEMPTS WERE MADE TO OBTAIN COMPLETE EVENT, PATIENT AND DEVICE INFORMATION. THE DEVICE WAS RECEIVED. INVESTIGATION IS NOT YET COMPLETE. A FOLLOW UP REPORT WILL BE SUBMITTED WITH ALL RELEVANT INFORMATION.

    Description of Event or Problem · 1

    SUBSEQUENT TO THE INITIAL 30-DAY MEDWATCH REPORT, THE FOLLOWING INFORMATION WAS RECEIVED: A 2.0 X 200 MM 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 WAS USED; AFTER DEFLATION REMOVAL WAS DIFFICULT, RESULTING IN THE SHAFT SEPARATION. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A PROCEDURE OF THE ANTERIOR TIBIAL ARTERY USING THE ANTIGRADE LEFT GROIN, THE ARMADA BALLOON WAS ADVANCED WITH SOME ANATOMICAL RESISTANCE AND WAS INFLATED AND DEFLATED WITHOUT ISSUE BUT THE DEVICE COULD NOT BE REMOVED. EVENTUALLY AFTER MANIPULATION THE ARMADA WAS RETRACTED, HOWEVER, THE SHAFT SEPARATED. THE ARMADA SHAFT WAS REMOVED SUCCESSFULLY ON THE GUIDE WIRE FROM THE ANATOMY. A DIFFERENT ARMADA 18 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.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    150627 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 5112541

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR