BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CHOICE (TM)

    MDR report key: 2507196 · Received March 28, 2012

    Report

    Report Number
    2134265-2012-01924
    Event Type
    Injury
    Date Received
    March 28, 2012
    Date of Event
    December 19, 2007
    Report Date
    March 5, 2012
    Manufacturer
    BOSTON SCIENTIFIC - COSTA RICA (COYOL)
    Product Code
    DQX
    PMA / PMN Number
    K970244
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, 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) CLINICAL STUDY. SAME PATIENT AS 2134265-2012-00006. SAME CASE AS 2134265-2012-01932 . IT WAS REPORTED THAT DURING A CORONARY ARTERY TREATMENT PROCEDURE THE PATIENT EXPERIENCED A SPASM. THE TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA) WITH 90 % STENOSIS AND WAS 17.0 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.75 MM. THE PHYSICIAN TREATED THE LESION WITH PRE-DILATATION USING A 2.50 X 15MM MAVERICK DILATATION CATHETER (INFLATED AT 6 AND 10 ATM) AND PLACEMENT OF A 3.5 X 24 MM TAXUS ELEMENT STENT. FOLLOWING POST-DILATATION RESIDUAL STENOSIS WAS 0%. DURING THE INDEX PROCEDURE A 0.14 CHOICE PTJ WIRE WAS ADVANCED ACROSS THE MID RCA AND A 2.5 X 15 MM LONG MAVERICK DILATING CATHETER AND THE STUDY STENT WAS DEPLOYED. WITH THE GUIDEWIRE STILL IN PLACE IN THE PROXIMAL RCA, THERE WAS 40-50% NARROWING APPEARED TO BE MORE SEVERE AFTER REMOVING THE GUIDEWIRE AND INTRACORONARY NITROGLYCERINE WAS ADMINISTERED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CHOICE (TM) WIRE, GUIDE, CATHETER DQX BOSTON SCIENTIFIC - COSTA RICA (COYOL) H74912132011

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention MAVERICK 2 BALLOON CATHETER