BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 3090374 · Received May 2, 2013

    Report

    Report Number
    2134265-2013-03225
    Event Type
    Injury
    Date Received
    May 2, 2013
    Date of Event
    February 23, 2010
    Report Date
    April 9, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). DEVICE EVALUATED BY MANUFACTURER: 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 PATIENT AS MDR ID# 2134265-2013-02834. SAME CASE AS MDR ID# 2134265-2013-02833. (B)(4). IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION, JAILING OCCURRED AND THE PATIENT EXPERIENCED CHEST PAIN. IN (B)(6) 2010, THE PATIENT WAS DIAGNOSED WITH STABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 80% STENOSED AND 30MM LONG TARGET LESION WAS LOCATED IN THE MID LEFT ANTERIOR DESCENDING ARTERY WITH A REFERENCE VESSEL DIAMETER OF 3.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATATION USING A 2.5 X 20 MM APEX BALLOON. CORE LAB REPORTS NOTED AN "EXTRALUMINAL 'C' DISSECTION WITH STAINING AFTER BALLOON PRE-DILATION WHICH WAS TREATED WITH PLACEMENT OF A 3.0 X 38 MM PROMUS ELEMENT STUDY STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT EXPERIENCED CHEST PAIN WITH EXERTION DURING BALLOON ANGIOPLASTY AND STENTING, THE CHEST PAIN WAS RESOLVED AFTER TREATMENT WITH INTRACORONARY NITROGLYCERINE AND DEFLATION. JAILING AT THE 2ND DIAGONAL WITH 70% OSTIAL STENOSIS WAS ALSO NOTED. NO FURTHER INTERVENTION WAS REQUIRED TO TREAT THE JAILING. IN ADDITION A NON-TARGET LESION LOCATED IN THE PROXIMAL LEFT CIRCUMFLEX ARTERY WAS TREATED WITH PLACEMENT OF A 2.5 X 18 MM NON STUDY DRUG ELUTING STENT, RESULTING IN 0% RESIDUAL STENOSIS. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191740 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention