BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMPHIRION DEEP PTA BALLOON CATHETER

    MDR report key: 6292184 · Received February 1, 2017

    Report

    Report Number
    9612164-2017-00094
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    June 26, 2016
    Report Date
    January 4, 2017
    Manufacturer
    MEDTRONIC MEXICO
    Product Code
    DQY
    PMA / PMN Number
    K052791
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DATE ARTICLE ACCEPTED AFTER REVISION JOURNAL ARTICLE PREDICTORS FOR BETTER BLOOD-FLOW RESTORATION OF LONG-SEGMENTAL BELOW-THE-KNEE CHRONIC TOTAL OCCLUSIONS AFTER ENDOVASCULAR THERAPY IN DIABETIC PATIENTS COPYRIGHT © 2016 THE KOREAN SOCIETY OF RADIOLOGY HTTPS://DOI.ORG/10.3348/KJR.2016.17.6.874 PISSN 1229-6929 · EISSN 2005-8330 ORIGINAL ARTICLE / INTERVENTION.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    SEVENTY FIVE PATIENTS WERE ENROLLED FOR THIS STUDY WITH 116 CTOS FOR RECANALIZATION. ONE HUNDRED AND SIX CTOS WERE SUCCESSFULLY RECANALIZED. TEN CTOS FAILED. THE REASONS FOR FAILURE WERE VESSEL PERFORATION IN 2 CTOS, FAILURE OF RE-ENTRY INTO THE TRUE LUMEN IN 6, AND THROMBOSIS IN 2. NINE OF THE 10 FAILED CTOS HAD POOR DISTAL RUNOFF FOR PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY. BAILOUT BTK STENT PLACEMENT WAS DONE IN 1 C ASE OWING TO ISOLATED DISSECTION.. NO PROCEDURE RELATED DEATH OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78031 AMPHIRION DEEP PTA BALLOON CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC MEXICO

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR