BEUDAMED
    FDA Adverse Event Injury Summary report: N

    IN.PACT ADMIRAL DCB

    MDR report key: 9496561 · Received December 19, 2019

    Report

    Report Number
    9612164-2019-05240
    Event Type
    Injury
    Date Received
    December 19, 2019
    Report Date
    December 19, 2019
    Manufacturer
    MEDTRONIC AORTIC AND PERIPHERAL VASCULAR
    Product Code
    ONU
    PMA / PMN Number
    P140010
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Description of Event or Problem · 0

    Unique Complaint ID Number,Initial or Supplement,Type of event,TTE in days,Device Brand Name,Medical device identifier,Device Codes;535979,I,SI,14,IN.PACT Admiral Paclitaxel-coated PTA Balloon Catheter,ADM05012008P ADM05012013P ADM05015008P ADM05015013P,C76126

    Additional Manufacturer Narrative · 1

    EXEMPTION NUMBER: E2017023. TOTAL NUMBER OF SERIOUS INJURY EVENTS BEING SUMMARIZED: 1. EXACT DATE OF EVENT UNKNOWN. IT WAS REPORTED THAT TWO IN.PACT ADMIRAL DEVICES WERE USED IN THE TREATMENT OF THIS PATIENT. THE BALLOON DIAMETER AND LENGTH ARE KNOWN, HOWEVER THE CATHETER LENGTH IS UNKNOWN. THE POSSIBLE DEVICE MODEL NUMBERS ARE ADM05012008P OR ADM05012013P, AND ADM05015008P OR ADM05015013P. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    THIS REPORT SUMMARIZES 1 SERIOUS INJURY REPORTED AS PART OF A BULK DATA RELEASE PROVIDED TO MEDTRONIC FROM THE SOCIETY FOR VASCULAR SURGERY - IN.PACT ADMIRAL VQI REGISTRY. THIS DATA HAS BEEN PROVIDED TO MEDTRONIC BY A THIRD PARTY (M2S) AND IS LIMITED AND DE-IDENTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1289576 IN.PACT ADMIRAL DCB DRUG-ELUTING PERIPHERAL TRANSLUMINAL ANGIOPLASTY CATHETER ONU MEDTRONIC AORTIC AND PERIPHERAL VASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention