BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PT2 GUIDE WIRE

    MDR report key: 4090275 · Received September 15, 2014

    Report

    Report Number
    2134265-2014-05557
    Event Type
    Injury
    Date Received
    September 15, 2014
    Date of Event
    August 7, 2014
    Report Date
    August 25, 2014
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K030617
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EG
    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

    IT WAS REPORTED THAT A PATIENT VESSEL DISSECTION OCCURRED. VASCULAR ACCESS WAS OBTAINED VIA THE RADIAL. THE 90% STENOSED, ECCENTRIC SHAPED, DE-NOVO TARGET LESION WAS LOCATED IN THE NON-TORTUOUS, NON-CALCIFIED, 3MM IN DIAMETER RIGHT CORONARY ARTERY (RCA). THE EJECTION FRACTION WAS 60%. A DISSECTION WAS NOTED IN THE RCA FOLLOWING WIRE INTRODUCTION OF A PT2 GUIDE WIRE, AND TWO OTHER NON-BSC GUIDE WIRES. THE DISSECTION WAS TREATED WITH STENT DEPLOYMENT. THERE WERE NO FURTHER PATIENT COMPLICATIONS AND THE PATIENT IS LISTED IN STABLE CONDITION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    568710 PT2 GUIDE WIRE WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) UNK507

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention