BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM

    MDR report key: 5254292 · Received November 30, 2015

    Report

    Report Number
    3003637635-2015-00002
    Event Type
    Malfunction
    Date Received
    November 30, 2015
    Date of Event
    October 20, 2015
    Report Date
    December 17, 2015
    Manufacturer
    CONTRACT MEDICAL INTERNATIONAL GMBH
    Product Code
    DYB
    PMA / PMN Number
    K100799
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    AS ALREADY MENTIONED IN INITIAL REPORT : THE EVENT OCCURRED ON 6FR FORTRESS WHICH IS NOT SOLD IN USA, BECAUSE IT HAS NOT BEEN FDA CLEARED YET. BUT THE 4FR FORTRESS FROM THE SAME DEVICE FAMILY 510(K) NUMBER (K100799) IS ALREADY SOLD IN USA. THEREFORE THE SUBMISSION IS PERFORMED. SAMPLE EVALUATION: ALL RETURNED 6FR SAMPLES WERE EVALUATED HOWEVER THE LEAKAGE THROUGH THE CONNECTION BETWEEN VALVE AND SHEATH IN THE AREA OF THE SWIVEL NUT DID NOT OCCUR. EACH SAMPLE WAS PRESSURIZED AT 3 BARS WITH HEATED WATER (37°C) SIMULATING BLOOD. THE LEAKAGE COULD NOT BE SIMULATED EVEN AFTER MANIPULATION WITH THE DEVICE (ROTATING THE COMPLETE INTRODUCER) SIMULATING PROCEDURE IN A HOSPITAL. THE JOINT DID NOT BECOME LOOSE. THE JOINT BECAME LOOSE ONLY AFTER UNSCREWING THE SWIVEL NUT BY HAND, WHICH IS AN EXPECTED BEHAVIOR. IT WAS POSSIBLE TO SCREW IT BACK IN PLACE WITH WATER IN THE SYSTEM WITHOUT ANY DIFFICULTIES. EVALUATION CONCLUSION - THE COMPLAINT DEFECT COULD NOT BE CONFIRMED. ROOT CAUSE : BECAUSE IT WAS NOT POSSIBLE TO REPRODUCE THE REPORTED DEFECT ON THE RETURNED SAMPLES, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED. CMI CONCLUDED THAT THE POTENTIAL ROOT CAUSE COULD BE USER ERROR. THIS IS HOWEVER JUST AN ASSUMPTION WITHOUT ANY OBJECTIVE EVIDENCE. CORRECTION: AFTER THE TESTING - NO CORRECTION POSSIBLE. ALL 6FR DEVICES WERE SCRAPPED CORRECTIVE ACTIONS: UPDATE OF PROCESS FMEA RELATED TO COMPLAINT EVENT PREVENTIVE ACTIONS: BASED ON CONFERENCE CALL WITH THE CUSTOMER BIOTRONIK ON 3RD OF (B)(6) 2015: CMI WILL RE-TRAIN OPERATORS FOR ASSEMBLING OF THE VALVE WITH THE SHEATH LUER HUB (PROCESS (B)(4)) CUSTOMER'S REPRESENTATIVES WILL PERFORM ADDITIONAL TRAINING OF PHYSICIANS FOR CORRECT HANDLING OF INTRODUCERS WITH A SWIVEL NUT FEATURE. THE 4FR SIZE WHICH IS SOLD IN USA HAS GOT DIFFERENT JOINT BETWEEN THE VALVE AND THE INTRODUCER IN COMPARISON TO 6FR . THERE IS A FIRM JOINT ON THE 4FR AND THE VALVE IS NOT REMOVABLE FROM THE INTRODUCER. THE VALVE ON THE 6FR IS REMOVABLE AND IT IS CONNECTED TO THE INTRODUCER WITH A LUER LOCK. BASED ON THAT THE LEAKAGE ON THE 4FR SIZE CAN NEVER OCCUR.

    Additional Manufacturer Narrative · 1

    THE CAUSE OF THE INCIDENT IS UNKNOWN AT THE TIME OF THIS REPORT. THE RETURNED DEVICE IS NOT AVAILABLE FOR AN INVESTIGATION BECAUSE IT IS BEING DECONTAMINATED BY AN EXTERNAL LAB. CMI' S PRELIMINARY ACTIONS: DEVICE HISTORY RECORDS (DHR ) OF THE AFFECTED LOT 598104 AND RELATED SUB-ASSEMBLIES WERE VERIFIED WITHOUT ANY NONCONFORMITY FOUND. IN THE AFFECTED LOT 598104, THE LOT 207538 OF THE VALVE SETS SET-(B)(4) WAS USED. THIS LOT (207538) PASSED AQL BASED INCOMING INSPECTION INCLUDING LEAK TESTING. ALL DEVICES FROM THE AFFECTED LOT PASSED 100% IN PROCESS AND AQL BASED QUALITY INSPECTIONS. THE CMI PRODUCTION PERSONNEL WAS INFORMED ABOUT THE COMPLAINT. BASED ON THE FACT THAT THE EXACT ROOT CAUSE OF THE INCIDENT IS NOT KNOWN AND THE EVENT HAS NOT CAUSED ANY HARM TO THE PATIENT, NO REMEDIAL ACTION IS INITIATED AT THE TIME OF THIS REPORT. POTENTIAL REMEDIAL ACTION WILL BE CONSIDERED WHEN THE DEVICE INVESTIGATION AND ROOT CAUSE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE EVENT OCCURRED ON 6FR FORTRESS WHICH IS NOT SOLD IN USA, BECAUSE IT HAS NOT BEEN FDA CLEARED YET. BUT THE 4FR FORTRESS FROM THE SAME DEVICE FAMILY 510(K) NUMBER (K100799) IS ALREADY SOLD IN USA. THEREFORE, THE SUBMISSION IS PERFORMED. THE EVENT OCCURED DURING USE IN PATIENT. THREE PIECES OF 6FR WERE USED AND WERE FOUND WITH THE LEAKY VALVE. THE WHOLE VALVE WAS LEAKING AND IT WAS NOT POSSIBLE TO LOCK IT IN PLACE. THE HOSPITAL WILL RETURN 26 PIECES FROM THE SAME LOT FOR AN INVESTIGATION. THERE WAS NO PATIENT INJURY. THE PATIENT WAS DISCHARGED HOME. THE 4FR SIZE WHICH IS SOLD IN USA HAS GOT DIFFERENT JOINT BETWEEN THE VALVE AND THE INTRODUCER IN COMPARISON TO 6FR . THERE IS A FIRM JOINT ON THE 4FR AND THE VALVE IS NOT REMOVABLE FROM THE INTRODUCER. THE VALVE ON THE 6FR IS REMOVABLE AND IT IS CONNECTED TO THE INTRODUCER WITH A LUER LOCK. BASED ON THAT THERE IS AN OPTION, THE LEAKAGE ON THE 4FR SHOULD NEVER OCCUR. HOWEVER, IT WILL BE CONFIRMED AFTER SAMPLE INVESTIGATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    786244 FORTRESS INTRODUCER SHEATH SYSTEM - 6FR, 45CM INTRODUCER, CATHETER DYB CONTRACT MEDICAL INTERNATIONAL GMBH FG-06551-001A 598104

    Patients

    Seq Age Sex Outcome Treatment
    1