BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    APEX BALLOON CATHETER

    MDR report key: 3150655 · Received June 6, 2013

    Report

    Report Number
    2134265-2013-04117
    Event Type
    Malfunction
    Date Received
    June 6, 2013
    Date of Event
    May 10, 2013
    Report Date
    May 14, 2013
    Manufacturer
    BOSTON SCIENTIFIC - MAPLE GROVE
    Product Code
    LOX
    PMA / PMN Number
    P860019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(6). (B)(4). DEVICE EVALUATED BY MFR: 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). SAME PATIENT AS MDR# 2134265-2010-04816, 2134265-2013-03198, 2134265-2013-03199, 2134265-2013-03582 AND 2134265-2013-03200. IT WAS REPORTED THAT DURING A TREATMENT PROCEDURE, A BALLOON RUPTURE OCCURRED. IN (B)(6) 2013, THE PATIENT WAS HOSPITALIZED. A CHRONIC TOTAL OCCLUSION (100% STENOSIS) WAS NOTED IN THE PREVIOUSLY IMPLANTED 2.5 X 23MM PROMUS STENT LOCATED IN THE DISTAL RIGHT CORONARY ARTERY (RCA). THE IN-STENT RESTENOSIS WAS TREATED USING A NON-BSC CROSSING CATHETER AND PREDILATATION USING A 2.0 X 12 MM EMERGE BALLOON. A FLEXTOME CUTTING BALLOON COULD NOT CROSS THE LESION AND A 2.5 X 12 MM APEX BALLOON WAS USED INSTEAD. AS THERE WAS STILL SOME STENOSIS NOTED, FURTHER DILATATION WAS COMPLETED. A 2.5 X 16 MM ION STENT WAS THEN DEPLOYED AND DURING POST-DILATATION WITH A 2.25 X 12 MM APEX BALLOON, A BALLOON RUPTURE OCCURRED. THE PROCEDURE WAS COMPLETED WITH A 2.5 X 12 MM APEX BALLOON, WITH 10% RESIDUAL STENOSIS. THE EVENT WAS CONSIDERED RESOLVED WITHOUT RESIDUAL EFFECTS AND THE PATIENT WAS DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250742 APEX BALLOON CATHETER CATHETERS, TRANSLUMINAL CORONARY ANGIOPLASTY, PERCUTANEOUS LOX BOSTON SCIENTIFIC - MAPLE GROVE UNK21

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR