BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    TD CATHETER

    MDR report key: 3848795 · Received March 12, 2014

    Report

    Report Number
    2025816-2014-00028
    Event Type
    Malfunction
    Date Received
    March 12, 2014
    Date of Event
    January 8, 2014
    Report Date
    February 10, 2014
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    DYG
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE RETURN: TWO (2) USED 41239-06 7F CATHETERS WERE RETURNED TO THE MFR. MFRS INVESTIGATION: VISUAL INSPECTION AND ANALYSIS OF THE TWO AS-RECEIVED 41239-06 7F CATHETERS RECORDED THE BALLOONS WERE DAMAGED/TORN. BASED ON THE VISUAL INSPECTION, THE REPORTED INFLATION FAILURE WAS CONFIRMED. ADD'L ENGINEERING ANALYSIS OF THE RETURNED CATHETER COMPONENTS IDENTIFIED NO DIMENSIONAL NON-CONFORMANCES AND/OR MFG. OUT OF SPEC CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE PRODUCT ISSUE. IT WAS REPORTED THAT THE 41239-06 CATHETERS WERE SUCCESSFULLY PRETESTED FOR INFLATION INTEGRITY WITH NO ISSUES NOTED AT THAT TIME. IT WAS ALSO REPORTED THAT A TERUMO 7F INTRODUCER SHEATH WAS USED. FOR OPTIMAL PERFORMANCE, THE 41239-06 7F CATHETER DIRECTIONS FOR USE (DFU) RECOMMENDS USE OF 8F OR LARGER FOR THE 41239-06 7F CATHETERS. ADDITIONAL INVESTIGATIONS: AS PART OF ICU MEDICALS CONTINUOUS IMPROVEMENT INITIATIVES A MULTI-DISCIPLINE TEAM WAS INITIATED TO PERFORM IN-DEPTH ANALYSIS OF CATHETER BALLOON INFLATION ISSUES. DETAILED ENGINEERING STUDIES, WHICH INCLUDED BALLOON RAW MATERIALS AGING PROPERTIES WERE PERFORMED. THIS STUDY EVALUATED BALLOON PERFORMANCE IMMEDIATELY AFTER PROCESSING AND AFTER ACCELERATED AGING. CONCURRENT WITH IN-HOUSE ENGINEERING STUDIES, A JOINT INVESTIGATION WAS ALSO INITIATED WITH THE MATERIAL VENDOR'S TECHNICAL AND ENGINEERING STAFFS TO IDENTIFY POTENTIAL FORMULATION ENHANCEMENTS AND PROCESSING IMPROVEMENTS. ALTHOUGH THESE EFFORTS ARE STILL IN PROGRESS SEVERAL INTERIM MEASURES HAVE BEEN IDENTIFIED, QUALIFIED AND IMPLEMENTED. THESE INCLUDE, BUT ARE NOT LIMITED TO MODIFICATION TO THE BALLOON FORMULATION MIXING PROCEDURE AND A PROCESS CHANGE TO THE MATERIAL ROLL-OUT. ADDITIONAL ENHANCEMENTS ARE IN VARIOUS STAGES OF VALIDATION AND IMPLEMENTATION. A REVIEW OF THE MFG LOT BUILD DATABASE FOR THE REPORTED LOT NUMBER 30-988-SJ (MFG DATE 07/2013) SHOWS (B)(4) UNITS WERE MFG., TESTED, INSPECTED AND RELEASED. THERE WERE NO EXCEPTION DOCUMENTS GENERATED DURING THE LOT BUILD. FINDINGS: BASED ON THE "AS-RECEIVED" CONDITION OF THE TWO RETURNED 41239-06 CATHETER THE REPORTED BALLOON INFLATION ISSUE WAS VERIFIED. THE EXACT CAUSE(S) OF THE CATH BALLOON DAMAGES ARE UNKNOWN AT THIS TIME. THE MFR WILL CONTINUE TO MONITOR AND TREND AND IMPLEMENT ANY PREVENTATIVE OR CORRECTIVE ACTIONS AS APPROPRIATE.

    Description of Event or Problem · 1

    COMPLAINT REC'D CONCERNING BALLOON INFLATION FAILURES WITH USE OF 41239-06 7F TD HEPARIN COATED CATHETERS. IT WAS REPORTED THAT AT UNSPECIFIED TIME DURING THE PROCEDURES, CATHETER INFLATION FAILURES OCCURRED. THERE WERE NO REPORTED ADVERSE PATIENT CONSEQUENCES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    148663 TD CATHETER TD CATHETER DYG ICU MEDICAL, INC. 41239-06 30-988-SJ

    Patients

    Seq Age Sex Outcome Treatment
    1 NI TERUMO 7FR INTRODUCER SHEATH