BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ARMADA 14 PTA CATHETER

    MDR report key: 12051970 · Received June 23, 2021

    Report

    Report Number
    2024168-2021-05338
    Event Type
    Injury
    Date Received
    June 23, 2021
    Date of Event
    June 3, 2021
    Report Date
    July 21, 2021
    Manufacturer
    ABBOTT VASCULAR
    Product Code
    DQY
    UDI-DI
    08717648156106
    PMA / PMN Number
    K102705
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR ANALYSIS. A REVIEW OF THE LOT HISTORY RECORD IDENTIFIED NO MANUFACTURING NONCONFORMITIES ISSUED TO THE REPORTED LOT THAT WOULD HAVE CONTRIBUTED TO THIS EVENT. IN THIS CASE, THERE WAS NO REPORTED DEVICE MALFUNCTION ASSOCIATED WITH THE ARMADA 14 BALLOON CATHETER. THE REPORTED PATIENT EFFECT OF EMBOLISM IS LISTED IN THE ARMADA 14 INSTRUCTION FOR USE AS A KNOWN POTENTIAL COMPLICATION THAT MAY OCCUR. BASED ON THE CASE INFORMATION, A CONCLUSIVE CAUSE FOR THE REPORTED PATIENT EFFECT(S) RESULTING IN UNEXPECTED MEDICAL INTERVENTION, AND THE RELATIONSHIP TO THE PRODUCT, IF ANY, CANNOT BE DETERMINED. THERE IS NO INDICATION OF A PRODUCT QUALITY ISSUE WITH RESPECT TO MANUFACTURE, DESIGN OR LABELING.E1, E3.

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS DISCARDED AND WILL NOT RETURN FOR ANALYSIS. INVESTIGATION IS NOT COMPLETE. A FOLLOW-UP REPORT WILL BE SUBMITTED WITH ALL ADDITIONAL RELEVANT INFORMATION. NA.

    Description of Event or Problem · 1

    PATIENT ID: (B)(6). IT WAS REPORTED THAT ON (B)(6) 2021, A PERCUTANEOUS INTERVENTION WAS PERFORMED ON THE RIGHT PERONEAL ARTERY LESION. PRE-DILATATION WAS SUCCESSFULLY PERFORMED USING ARMADA CATHETERS AND A 4.0X18MM XIENCE ALPINE STENT WAS SUCCESSFULLY IMPLANTED. ANGIOPLASTY WAS THEN PERFORMED USING ARMADA DILATATION CATHETERS IN THE DORSALIS PEDAL ARTERY WITH SUBTOTAL OCCLUSION. FOLLOWING USE OF ARMADA (A2030-120, 0112541), A THROMBUS/EMBOLISM WAS OBSERVED IN THE PROXIMAL PEDAL ARTERY, SUCCESSFULLY TREATED WITH A THROMBECTOMY. THE EVENT RESOLVED WITHOUT SEQUELA. REPORTEDLY, THERE WAS NO DEVICE MALFUNCTION. NO ADDITIONAL INFORMATION WAS PROVIDED REGARDING THIS ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    951616 ARMADA 14 PTA CATHETER PERIPHERAL DILATATION CATHETER DQY ABBOTT VASCULAR A2030-120 0112541 08717648156106

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention XIENCE ALPINE STENT