BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LAUNCHER 6F GUIDE CATHETER

    MDR report key: 6278732 · Received January 26, 2017

    Report

    Report Number
    1220452-2017-00005
    Event Type
    Injury
    Date Received
    January 26, 2017
    Report Date
    December 27, 2016
    Manufacturer
    MEDTRONIC, INC
    Product Code
    DQY
    PMA / PMN Number
    K021256
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    JOURNAL: CANADIAN JOURNAL OF CARDIOLOGY 32 (2016) 1425-1432 TITLE OF ARTICLE: A RANDOMIZED STUDY OF SHEATHLESS VS STANDARD GUIDING CATHETERS FOR TRANSRADIAL PERCUTANEOUS CORONARY INTERVENTIONS. RECEIVED FOR PUBLICATION DECEMBER 26, 2015. ACCEPTED MARCH 27, 2016. HTTP://DX.DOI.ORG/10.1016/J.CJCA.2016.03.016. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    BETWEEN 2011 AND 2013, TRANSRADIAL PCIS PERFORMED USING STANDARD GC (MEDTRONIC LAUNCHER) AND THE NON-MDT SHEATHLESS EAUCATH GC. THE GOAL OF THE STUDY WAS TO COMPARE THE 6-F GC VS THE 6.5-F SHEATHLESS GC IN ROUTINE PCI IN WOMEN AND THE 7-F GC WITH THE 7.5 SHEATHLESS GC IN MEN WHO UNDERWENT COMPLEX PCI (EG, BIFURCATION LESIONS OR LEFT ANTERIOR DESCENDING [LAD] ARTERY AND/OR LEFT CIRCUMFLEX [LCX] OSTIAL LESIONS). IN CONCLUSION, THE USE OF THE SHEATHLESS GC IN SELECTED CORONARY LESIONS REQUIRING LARGE-BORE CATHETERS IN MEN AND IN ALL LESIONS IN WOMEN WAS SAFE AND SUPERIOR TO THE USE OF THE STANDARD GC WHEN CONSIDERING SUCCESSFUL TRANSRADIAL PCI WITH THE DESIGNATED GC. COMPLICATION LISTED INCLUDED PSEUDO ANEURYSM AND OCCLUSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    63215 LAUNCHER 6F GUIDE CATHETER CATHETER, PERCUTANEOUS DQY MEDTRONIC, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR