BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUANTUM MAVERICK BALLOON CATHETER

    MDR report key: 3813172 · Received May 15, 2014

    Report

    Report Number
    2134265-2014-02598
    Event Type
    Injury
    Date Received
    May 15, 2014
    Date of Event
    April 18, 2007
    Report Date
    April 17, 2014
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, 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

    (B)(4). IT WAS REPORTED THAT CHEST PAIN OCCURRED. ON (B)(6) 2007, THE PATIENT PRESENTED WITH RECURRENT CHEST PAIN AND WAS DIAGNOSED WITH CORONARY ARTERY DISEASE. PATIENT WAS REFERRED FOR DOUBLE VESSEL INTERVENTION FOR LEFT ANTERIOR DESCENDING (LAD) AND LEFT CIRCUMFLEX (LCX). VASCULAR ACCESS WAS OBTAINED USING A 6FR NON-BSC SHEATH INTO THE RIGHT FEMORAL ARTERY. THE 80% STENOSED TARGET LESION # 1 WAS LOCATED IN THE PROXIMAL LAD. AN 6FR NON-BSC GUIDE CATHETER WAS ADVANCED TO THE LEFT CORONARY OSTIUM. INITIAL GUIDING SHOTS WERE OBTAINED AFTER INTRACORONARY NITROGLYCERIN WAS GIVEN. SUBSEQUENTLY, AFTER A 0.14X300CM NON-BSC GUIDE WIRE WAS CROSSED, A 3.5X20MM TAXUS STENT WAS DEPLOYED AT 18ATMOSPHERES. REPEAT ANGIOGRAPHY REVEALED MILD RESIDUAL STENOSIS. A 75X50MM QUANTUM BALLOON CATHETER WAS THEN ADVANCED OVER THE WIRE AND 2 INFLATIONS WERE PERFORMED AT 14 ATMOSPHERES. HOWEVER DURING INFLATIONS, PATIENT COMPLAINED OF CHEST PAIN WHICH RESOLVED AFTER DEFLATING THE BALLOON AND FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 0%. TARGET LESION # 2 WAS A 90% STENOSED LESION LOCATED IN THE MID LCX IN THE OSTIUM OF THE AV GROOVE IMMEDIATELY TAKE OFF OF A MODERATE SIZE OBTUSE MARGINAL (OM) BRANCH. AFTER A NON-BSC GUIDE WIRE WAS CROSSED THE LESION, A 2.5X10MM NON-BSC BALLOON CATHETER WAS ADVANCED AND INFLATED THRICE. REPEAT ANGIOGRAPHY REVEALED PLAQUE SHIFTING IN THE OSTIUM OF OM AND RESIDUAL STENOSIS IN THE AV GROOVE BRANCH. HENCE, A 3.0X 16MM TAXUS DRUG ELUTING STENT WAS ADVANCED AND WAS DEPLOYED SUCCESSFULLY AT 12ATMOSPHERES. IN RESULT, JAILING THE TAKE OFF OF THE OM AND 70-80% STENOSIS WAS NOTED. THE PHYSICIAN TREATED WITH A 2.5X 10MM NON-BSC BALLOON CATHETER WAS INFLATED TWICE UP TO 8ATMOSPHERES. DURING THIS PROCEDURE, PATIENT RECEIVED MEDICATIONS, IV HEPARIN, INTEGRILIN AND BOLUSES OF INTRACORONARY NITROGLYCERINE. FOLLOWING POST PROCEDURE, THE PATIENT WAS DISCHARGED ON PLAVIX AND ASPIRIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290468 QUANTUM MAVERICK BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK351

    Patients

    Seq Age Sex Outcome Treatment
    1 36 YR Required Intervention