BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MACH1 GUIDE CATHETER

    MDR report key: 3033644 · Received April 3, 2013

    Report

    Report Number
    2134265-2013-01959
    Event Type
    Injury
    Date Received
    April 3, 2013
    Date of Event
    January 31, 2008
    Report Date
    March 5, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    DQY
    PMA / PMN Number
    K020028
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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). IT WAS REPORTED THAT DURING A CORONARY ARTERY STENTING TREATMENT PROCEDURE THE PATIENT EXPERIENCED A VASOSPASM. THE TARGET LESION WAS LOCATED IN THE 2ND OBTUSE MARGINAL (OM) WITH 99% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.25 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION AND PLACEMENT OF A 2.25 X 24 MM STUDY STENT. DURING THE INDEX PROCEDURE, AFTER INSERTING A MACH 1 GUIDE CATHETER A VASOSPASM WAS NOTED. THIS WAS TREATED WITH ADMINISTRATION OF VERAPAMIL IA. FOLLOWING THE POST DILATATION RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    137065 MACH1 GUIDE CATHETER CATHETER, PERCUTANEOUS DQY BOSTON SCIENTIFIC - MAPLE GROVE UNK497

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Required Intervention