BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CORONARY SINUS BALLOON VENOGRAPHY CATH

    MDR report key: 6208715 · Received December 28, 2016

    Report

    Report Number
    2523676-2016-00898
    Event Type
    Malfunction
    Date Received
    December 28, 2016
    Date of Event
    August 25, 2016
    Report Date
    September 28, 2016
    Manufacturer
    B. BRAUN MEDICAL INC.
    Product Code
    DYG
    UDI-DI
    04046964325823
    PMA / PMN Number
    K822806
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. (B)(4). ONE USED BALLOON CATHETER SET WITHOUT PACKAGING AND ONE USED TERUMO 12 CC "SINGLE USE SYRINGE" WAS RETURNED FOR EVALUATION. VISUAL EXAMINATION OF THE SET NOTED NO VISUAL ISSUES. THE SYRINGE WAS EXAMINED AND IT WAS NOTED SOME LIQUID WAS STILL INSIDE THE SYRINGE. THE AIR LINE OF THE DEVICE WAS ACCESSED USING A OMNIFIX SYRINGE FILLED WITH 1.5 CC OF AIR. THE BALLOON WAS INFLATED, HOWEVER THE BALLOON COULD NOT DEFLATE. AN OCCLUSION TEST WAS PERFORMED PER SPECIFICATION. THE GUIDE WIRE PASSED FULLY THROUGH THE DEVICES WITH NO ISSUES NOTED, PASSING THE OCCLUSION TEST. THE DEVICE WAS SECTIONED OFF STARTING FROM THE DISTAL END, AND THE AIR BALLOON LINE EXAMINED DURING EACH SECTIONING. WHEN THE MOLDED MANIFOLD SECTION WAS SECTIONED, LIQUID WAS NOTED TO BE PRESENT INSIDE THE AIR BALLOON LINE. THE CUT MOLDED MANIFOLD SECTION WAS EXAMINED UNDER THE RAM OPTICAL, AND CONFIRMED LIQUID TO BE PRESENT INSIDE THE AIR BALLOON LINE. HOWEVER, THERE WAS NOTE ENOUGH LIQUID INSIDE THE AIR BALLOON LINE TO TEST. THE LIQUID FOUND INSIDE AIR BALLOON LINE PREVENTED THE BALLOON CATHETER FROM DEFLATING. INCIDENTS OF THIS NATURE ARE CONSISTENT WITH INCORRECT USER INTERACTION WITH THE PRODUCT. PER THE INSTRUCTIONS FOR USE (IFU), "DO NOT USE LIQUIDS AS A BALLOON INFLATION MEDIA". REVIEW OF THE DISCREPANCY MANAGEMENT SYSTEM DATABASE PERFORMED FOR THE REPORTED LOT NUMBER DID NOT REVEAL ANY ABNORMALITIES OR NONCONFORMANCES OF THIS NATURE. NO ADVERSE QUALITY TRENDS OF THIS NATURE WERE IDENTIFIED DURING THE COMPLAINT REVIEW PROCESS FOR THE REPORTED CATALOG NUMBER OR LOT NUMBER. NOTE: THIS CASE IS BEING FILED RETROSPECTIVELY AS A RESULT OF A REVIEW OF RECENT CUSTOMER COMPLAINT INFORMATION. BASED ON ADDITIONAL INFORMATION AND DETAILS PROVIDED IN ANOTHER COMPLAINT CASE, IT WAS DETERMINED THAT THIS CASE IS REPORTABLE IN ACCORDANCE WITH THE REQUIREMENTS OF 21 CFR 803. B. BRAUN HAS CONDUCTED A RETROSPECTIVE REVIEW FOR ALL COMPLAINTS OF A SIMILAR NATURE IN ACCORDANCE WITH INTERNAL PROCEDURE (B)(4).

    Description of Event or Problem · 1

    AS REPORTED BY USER FACILITY: BALLOON CATHETER WAS INSERTED TO OBTAIN A CS VENOGRAM. THE BALLOON CANNOT BE DEFLATED. THE PHYSICIAN DECIDED TO INJECT MORE AIR TO THE BALLOON CATHETER AND THE BALLOON RUPTURED. NO PATIENT INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    861508 CORONARY SINUS BALLOON VENOGRAPHY CATH CATHETER, FLOW DIRECTED DYG B. BRAUN MEDICAL INC. 0061384742 04046964325823

    Patients

    Seq Age Sex Outcome Treatment
    1