BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 3606061 · Received February 4, 2014

    Report

    Report Number
    2134265-2014-00322
    Event Type
    Injury
    Date Received
    February 4, 2014
    Date of Event
    January 5, 2012
    Report Date
    January 16, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    K121667
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE DEVICE WAS NOT RECEIVED FOR ANALYSIS. THE BATCH NUMBER IS UNKNOWN AND THE MANUFACTURING RECORDS FOR THE COMPLAINT DEVICE COULD NOT BE REVIEWED. THE ROOT CAUSE IS ANTICIPATED PROCEDURAL COMPLICATIONS AS THIS EVENT IS A KNOWN PHYSIOLOGICAL EFFECT OF THE PROCEDURE AND IS NOTED WITHIN THE DFU. (B)(4).

    Description of Event or Problem · 1

    SAME CASE AS MDR ID # 2134265-2014-00325. (B)(4) CLINICAL STUDY. IT WAS REPORTED THAT A CHEST PRESSURE OCCURRED. IN (B)(6) 2012, THE SUBJECT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION AND INDEX PROCEDURE WAS PERFORMED. THE SUBJECT WAS ENROLLED IN THE (B)(4) STUDY. TARGET LESION #1 WAS A IN STENT STENOTIC LESION (UNKNOWN DES) LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY (LAD)WITH 90-95% STENOSIS AND WAS 16 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. TARGET LESION WAS TREATED WITH DIRECT STENT PLACEMENT USING A 3.00 MM X 20 MM ION STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. AFTER THE IMPLANTATION OF 3 X 20 MM (B)(4) STUDY STENT AND POST DILATATION WITH 3.25 MM X 12MM NC QUANTUM APEX BALLOON CATHETER, CHEST PRESSURE REPORTED (8/10 ON PAIN SCALE) BY THE SUBJECT. FENTANYL IV 25 MG WAS GIVEN TO TREAT THIS EVENT. THE SUBJECT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    71647 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Required Intervention