BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 3863979 · Received June 10, 2014

    Report

    Report Number
    2134265-2014-03205
    Event Type
    Injury
    Date Received
    June 10, 2014
    Date of Event
    May 28, 2009
    Report Date
    May 13, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE EVALUATED BY MFR: THE COMPLAINT 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 2134265-2014-03101. (B)(4). IT WAS REPORTED THAT ST ELEVATION OCCURED. ON (B)(6) 2009, CLINICAL STATUS ASSESSMENT IDENTIFIED THE PATIENT¿S QUALIFYING CONDITION AS STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. SUBSEQUENTLY, THE INDEX PROCEDURE WAS PERFORMED. THE 95% STENOSED, 2.50MM X 23MM TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING (LAD) ARTERY. A 2.00MM X 15MM APEX¿ BALLOON CATHETER WAS ADVANCED FOR PREDILATATION. HOWEVER, PER BASELINE ANGIOGRAPHY REPORT, GRADE B DISSECTION WAS NOTED AND THE PHYSICIAN TREATED THE EVENT WITH IMPLANTATION OF AN UNSPECIFIED STENT AND THE FINAL RESULT WAS GOOD. SUBSEQUENTLY, PHYSICIAN PERFORMED FURTHER PRE-DILATATION WITH UNSPECIFIED SIZE QUANTUM BALLOON CATHETER AND PLACEMENT OF A 2.50 X 28MM STUDY STENT. DURING IMPLANTATION OF THE STUDY STENT WITH STENT BALLOON, ST ELEVATION WERE NOTED UPON BALLOON INFLATIONS. SUBSEQUENTLY, THE STENT BALLOON WAS REMOVED. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. ONE DAY POST PROCEDURE, TROPONIN VALUES WERE INCREASED AND REPORTED AS EVENT OF MI. ONE DAY POST PROCEDURE, THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    341116 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK351

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention