BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 2850671 · Received November 29, 2012

    Report

    Report Number
    2134265-2012-07229
    Event Type
    Injury
    Date Received
    November 29, 2012
    Date of Event
    August 25, 2009
    Report Date
    November 2, 2012
    Manufacturer
    BOSTON SCIENTIFIC - GALWAY
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). 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 PATIENT AS MDR# 2134265-2012-05841. IT WAS REPORTED THAT DURING A STENTING TREATMENT PROCEDURE, VESSEL DISSECTION OCCURRED. IN (B)(6) 2009, THE PATIENT PRESENTED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 14MM X 3.25MM, 80% STENOSED, TARGET LESION WAS LOCATED IN THE MID RIGHT CORONARY ARTERY (RCA). THE TARGET LESION WAS PRE-DILATED WITH A 3.0 X 12 MM APEX BALLOON AND A TYPE B DISSECTION OCCURRED. THE DISSECTION AND TARGET LESION WERE TREATED WITH A 3.5 X 20MM PROMUS ELEMENT STENT, WITH 0% RESIDUAL STENOSIS AND GOOD RESULT. THE PATIENT WAS DISCHARGED THE NEXT DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - GALWAY UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention