BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 1833651 · Received September 14, 2010

    Report

    Report Number
    2134265-2010-04066
    Event Type
    Injury
    Date Received
    September 14, 2010
    Date of Event
    May 4, 2010
    Report Date
    August 25, 2010
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).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 DURING A CORONARY STENTING TREATMENT PROCEDURE, A DISSECTION OCCURRED. THE TARGET LESION BEING TREATED WAS LOCATED IN THE DISTAL LEFT CIRCUMFLEX (LCX). THE LESION WAS 75% STENOSED, 2.75MM IN DIAMETER AND 14MM LONG. THE LESION WAS TREATED WITH PREDILATION AND PLACEMENT OF A 2.50X18/20MM STUDY STENT. DURING THE INDEX, IT WAS NOTED THAT A DISSECTION OCCURRED PROXIMAL TO THE TARGET LESION BY AN UNKNOWN SIZE APEX BALLOON. THE DISSECTION WAS TREATED WITH A 2.75X15MM NON-STUDY DRUG ELUTING STENT. POST DILATION WAS PERFORMED. RESIDUAL STENOSIS WAS 0%. THE PATIENT WAS DISCHARGED 1 DAY LATER ON ASPIRIN AND CLOPIDOGREL. IN (B)(6) 2010, THE PATIENT EXPERIENCED NON-CARDIAC CHEST PAIN. A 30 DAY FOLLOW-UP REVEALED UNSTABLE ANGINA. AN ANGIOGRAPHY WAS PERFORMED BUT NO REVASCULARIZATION WAS REQUIRED. THE EVENT WAS SUCCESSFULLY RESOLVED WITHOUT RESIDUAL EFFECTS. THE PATIENT WAS DISCHARGED 2 DAYS LATER.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention