BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER

    MDR report key: 12561327 · Received October 1, 2021

    Report

    Report Number
    1220452-2021-00060
    Event Type
    Injury
    Date Received
    October 1, 2021
    Date of Event
    August 22, 2020
    Report Date
    October 1, 2021
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K132673
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PL
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL ARTICLE: TRANSRADIAL VERSUS TRANSULNAR ARTERY APPROACH FOR ELECTIVE INVASIVE PERCUTANEOUS CORONARY INTERVENTIONS: A RANDOMIZED TRIAL ON THE FEASIBILITY AND SAFETY WITH ULTRASONOGRAPHIC OUTCOME ¿ RAUL STUDY AUTHORS: DAGMARA GRALAK-LACHOWSKA, PAWEL J. LEWANDOWSKI, PAWEL MACIEJEWSKI, BOGUMIL RAMOTOWSKI, ANDRZEJ BUDAJ, SEBASTIAN STEC JOURNAL: ADVANCES IN INTERVENTIONAL CARDIOLOGY YEAR: 2020 REFERENCE: DOI: HTTPS://DOI.ORG/10.5114/AIC.2020.101761. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    A JOURNAL ARTICLE ENTITLED - TRANSRADIAL VERSUS TRANSULNAR ARTERY APPROACH FOR ELECTIVE INVASIVE PERCUTANEOUS CORONARY INTERVENTIONS: A RANDOMIZED TRIAL ON THE FEASIBILITY AND SAFETY WITH ULTRASONOGRAPHIC OUTCOME ¿ RAUL STUDY - WAS SUBMITTED FOR REVIEW. THE AIM OF THE STUDY WAS TO COMPARE THE SAFETY AND EFFICACY OF TRANSRADIAL ACCESS (TRA) AND TRANSULNAR ACCESS (TUA) IN PATIENTS SCHEDULED FOR CORONARY ANGIOGRAPHY (CAG). THE PRIMARY ENDPOINT OF THE STUDY WAS EFFICACY, DEFINED AS SUCCESSFUL CAG WITHOUT A CROSSOVER OF VASCULAR ACCESS. THE SECONDARY ENDPOINT WAS SAFETY, ASSESSED AS THE NUMBER OF VASCULAR COMPLICATIONS. TWO HUNDRED PATIENTS REFERRED FOR THE FIRST ELECTIVE CAG WERE INCLUDED IN THE STUDY. 6F LAUNCHER GUIDE CATHETERS WERE USED IN THE STUDY CAG PROCEDURES. CLINICAL OUTCOMES AT SIX-MONTH FOLLOW-UP INCLUDED VESSEL SPASM, PAINFUL PROCEDURE, TOTAL ARTERY OCCLUSION, PSEUDOANEURYSMS, HEMATOMA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456750 LAUNCHER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR