BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ARMADA 18 PTA CATHETER

    MDR report key: 6119216 · Received November 21, 2016

    Report

    Report Number
    2024168-2016-08213
    Event Type
    Malfunction
    Date Received
    November 21, 2016
    Date of Event
    September 21, 2016
    Report Date
    November 21, 2016
    Manufacturer
    AV-TEMECULA-CT
    Product Code
    LIT
    UDI-DI
    08717648211584
    PMA / PMN Number
    K151317
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). VISUAL INSPECTION WAS PERFORMED ON THE RETURNED DEVICE. A BALLOON RUPTURE, SCRATCHED BALLOON AND KINKS WERE NOTED DURING RETURN ANALYSIS. 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 THE DESIGN, MANUFACTURE, OR LABELING OF THE DEVICE. AS THERE WAS NO INFORMATION PROVIDED IN THE CASE DESCRIPTION, THE INVESTIGATION WAS UNABLE TO DETERMINE A CONCLUSIVE CAUSE FOR THE DAMAGES OBSERVED DURING RETURN DEVICE ANALYSIS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE 6.0 X 20 MM ARMADA 18 BALLOON CATHETER WAS RETURNED TO THE RETURNED GOODS LAB; HOWEVER, THERE IS NO INDICATION OF THE DEVICE ISSUE PROVIDED WITH THE DEVICE. NO ADVERSE PATIENT EFFECTS WERE REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED. RETURNED DEVICE ANALYSIS REVEALED A BALLOON RUPTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    766813 ARMADA 18 PTA CATHETER PERIPHERAL DILATATION CATHETER LIT AV-TEMECULA-CT 6061441 08717648211584

    Patients

    Seq Age Sex Outcome Treatment
    1