BEUDAMED
    FDA Adverse Event Injury Summary report: N

    NC QUANTUM APEX BALLOON CATHETER

    MDR report key: 2992286 · Received March 7, 2013

    Report

    Report Number
    2134265-2013-01231
    Event Type
    Injury
    Date Received
    March 7, 2013
    Date of Event
    December 17, 2012
    Report Date
    February 7, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    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 CASE AS MDR ID# 2134265-2013-01219. SAME CASE AS MDR ID# 2134265-2013-01220. SAME CASE AS MDR ID# 2134265-2013-00129. (B)(4) STUDY. IT WAS REPORTED THAT DURING A PERCUTANEOUS CORONARY INTERVENTION TREATMENT PROCEDURE, VESSEL SPASMS OCCURRED. IN (B)(6) 2012 THE PATIENT PRESENTED WITH UNSTABLE ANGINA AND WAS REFERRED FOR CARDIAC CATHETERIZATION. THE 70% STENOSED AND 35MM LONG DE-NOVO TARGET LESION WAS LOCATED IN THE PROXIMAL RIGHT CORONARY ARTERY (RAC) WITH A REFERENCE VESSEL DIAMETER OF 4.0MM. THE TARGET LESION WAS TREATED WITH PRE-DILATION USING A 3.0X15MM APEX BALLOON CATHETER FOLLOWED BY PLACEMENT OF A 4.0X28 MM PROMUS ELEMENT PLUS STENT. POST STENT DEPLOYMENT A PROXIMAL EDGE DISSECTION WAS NOTED. THE DISSECTION WAS TREATED WITH A 4.0X8.0 MM PROMUS ELEMENT PLUS STENT, RESULTING IN 0% RESIDUAL STENOSIS FOLLOWING POST DILATION USING A 4.5MM APEX BALLOON CATHETER. FOLLOWING POST-DILATION SLOW FLOW AND DISTAL SPASMS WERE NOTED WHICH IMPROVED FOLLOWING MULTIPLE DOSES OF ADENOSINE AND NITROGLYCERIN. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED THE FOLLOWING DAY ON ASPIRIN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    97748 NC QUANTUM APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK651

    Patients

    Seq Age Sex Outcome Treatment
    1 51 Required Intervention