BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 3180226 · Received June 20, 2013

    Report

    Report Number
    2134265-2013-04302
    Event Type
    Injury
    Date Received
    June 20, 2013
    Date of Event
    May 14, 2013
    Report Date
    May 24, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FI
    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

    (B)(4). SAME CASE AS MDR ID: 2134265-2013-04303. IT WAS REPORTED THAT DURING A CORONARY STENTING TREATMENT PROCEDURE, PATIENT EXPERIENCED ANGINA PECTORIS, SEVERE CHEST PAIN AND TIMI I FLOW OCCURRED. THE SUBJECT PRESENTED WITH STABLE ANGINA AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A LESION LOCATED IN THE MID SEGMENT OF LEFT ANTERIOR DESCENDING ARTERY WITH 70% STENOSIS AND WAS 12 MM LONG WITH A REFERENCE VESSEL DIAMETER OF 3 MM. IT WAS TREATED WITH PRE-DILATATION AND PLACEMENT OF A 3.00 X 20 MM STUDY STENT. FOLLOWING POST DILATATION, RESIDUAL STENOSIS WAS 20%. ON (B)(6) 2013, THE PATIENT PRESENTED WITH COMPLAINTS OF SHORTNESS OF BREATH ASSOCIATED DURING PHYSICAL EXERTION WITH HEARTBURN AND NUMBNESS OF LEFT ARM AND UNDERWENT CARDIAC CATHETERIZATION WHICH REVEALED A 75% MILD STENOSIS; MILD WALL CHANGES IN THE DIAGONAL OF THE LEFT ANTERIOR DESCENDING ARTERY. THE 70% STENOSIS IN MID SEGMENT OF LEFT ANTERIOR DESCENDING ARTERY WAS TREATED WITH PREDILATATION, PLACEMENT OF A 3 X 20 MM STUDY STENT AND POST DILATATION USING A 3.5 X 12 MM NC QUANTUM BALLOON. FOLLOWING POST DILATATION, THE SUBJECT DEVELOPED SEVERE CHEST PAIN. TIMI FLOW 1 WAS OBSERVED DOWN THE 1ST DIAGONAL. THE SUBJECT WAS TREATED WITH NTG AND OXANEST. AFTER REMOVAL OF THE GUIDEWIRE, TIMI FLOW III WAS NOTED. THE CHEST PAIN IMPROVED GRADUALLY AFTER TREATMENT WITH 2 MG INTRAVENOUS MO. FOLLOWING THE PROCEDURE THE PATIENT EXPERIENCED A CARDIAC ENZYMES LEVEL ELEVATION (PEAK TROPONIN= 0.41 NG/ML, ULN= 0.02 NG/ML) WHICH IS CONSISTENT WITH THE DEFINITION OF MYOCARDIAL INFARCTION. THE SUBJECT WAS TREATED WITH MEDICATIONS AND TWO DAYS AFTER, THE SUBJECT WAS DISCHARGED ON DUAL ANTIPLATELET THERAPY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280277 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