BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 3043094 · Received April 9, 2013

    Report

    Report Number
    2134265-2013-02402
    Event Type
    Injury
    Date Received
    April 9, 2013
    Date of Event
    November 19, 2012
    Report Date
    March 11, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MANUFACTURER: IT IS INDICATED THAT THE DEVICE WILL NOT BE RETURNED FOR EVALUATION; THEREFORE A FAILURE ANALYSIS OF THE COMPLAINT DEVICE COULD NOT BE COMPLETED. A REVIEW OF THE BATCH HISTORY, HISTORICAL TRENDING, AND SIMILAR COMPLAINT TRENDING REVIEW FOR THE PRODUCT FAMILY WILL BE CONDUCTED. IF THERE IS ANY FURTHER RELEVANT INFORMATION FROM THAT REVIEW, A SUPPLEMENTAL MEDWATCH WILL BE FILED. (B)(4).

    Description of Event or Problem · 1

    (B)(4). SAME CASE AS: 2134265-2013-02401. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE VESSEL PERFORATION OCCURRED. THE PATIENT DIAGNOSED WITH UNSTABLE ANGINA IN (B)(6) 2012 AND UNDERWENT A CARDIAC CATHETERIZATION. TARGET LESION ONE WAS A 95% STENOSED DE-NOVO LESION LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH A REFERENCE VESSEL DIAMETER OF 3.50MM AND A LESION LENGTH OF 12MM. THE LESION WAS CANNULATED WITH JR 4 SH 6FR MACH1 GUIDING CATHETER AND 3.50 X 16 MM PROMUS ELEMENT PLUS STENT WAS DEPLOYED, RESULTING IN 0% RESIDUAL STENOSIS AND A PERFORATION WAS NOTED AT THE INTERVENTION SITE. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    145562 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE H749343566920

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention STENT: PROMUS ELEMENT PLUS STENT 3.50X16MM