BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 3881695 · Received June 18, 2014

    Report

    Report Number
    2134265-2014-03832
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    May 30, 2013
    Report Date
    June 6, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR.: 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

    SAME CASE AS MDR ID: 2134265-2014-03833. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT SPASM OCCURED. IN (B)(6) 2013, THE PATIENT WAS PRESENTED DUE TO UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE INDEX PROCEDURE WAS PERFORMED. TARGET LESION #1 WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX) (MID LCX) EXTENDING INTO THE 2ND OBTIUS MARGINAL (OM) WITH 90% STENOSIS, WAS 30 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 2.5 MM. THE LESION WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 2.5 X 38 MM STUDY STENT. FOLLOWING POSTDILATATION WITH A 3 X 8 MM APEX BALLOON, SPASM IN LCX WAS NOTED WHICH WAS TREATED WITH 300 MCG INTRACORONARY NITROGLYCERIN. RESIDUAL STENOSIS WAS 0%. TARGET LESION #2 WAS LOCATED IN THE PROXIMAL LCX WITH 90% STENOSIS AND WAS 8 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. PRE-DILATION WAS PERFORMED WITH 3.0 X 8 MM APEX BALLOON AND RESULTED IN A SMALL LOCALIZED INTIMAL TEAR. THE LESION WAS THEN TREATED WITH PLACEMENT OF A 3.5 X 12 MM STUDY STENT WITH 0% RESIDUAL STENOSIS. TARGET LESION #3 WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RCA) WITH 90% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3.5 MM. FOLLOWING PRE-DILATATION USING A 3 X 8 MM APEX BALLOON CATHETER, SPASM WAS NOTED AND WAS TREATED WITH 200 MCG INTRACORONARY NITROGLYCERIN. FOLLOWING PLACEMENT OF THE 3.5 X 20 MM STUDY STENT, POSTDILATATION WAS DONE USING A 4 X 12 MM NC QUANTUM APEX BALLOON CATHETER AND SPASM WAS NOTED SUBSEQUENTLY, WHICH WAS TREATED WITH 400 MCG INTRACORONARY NITROGLYCERIN. RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    358880 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention