BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RADIFOCUS INTRODUCER II KIT

    MDR report key: 5319590 · Received December 22, 2015

    Report

    Report Number
    1118880-2015-00088
    Event Type
    Malfunction
    Date Received
    December 22, 2015
    Report Date
    December 22, 2015
    Manufacturer
    TERUMO MEDICAL CORPORATION
    Product Code
    DYB
    PMA / PMN Number
    K954234
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 FOR MFG. REPORT NO. 1118880-2015-00088 TO PROVIDE A STATUS UPDATE ON THE EVALUATION AS WELL AS TO CORRECT THE ACTUAL DEVICE WAS RETURNED TO THE MANUFACTURING FACILITY AND THE EVALUATION IS CURRENTLY ONGOING. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE, BUT NO LATER THAN 30 DAYS FROM THE DATE THAT THIS REPORT WAS SENT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    (B)(4): ALTHOUGH THERE WERE REPORTEDLY NO IMPACT TO THE PATIENT, THE EVENT DESCRIPTION INDICATES THAT SOME BLOOD LOSS DID OCCUR. THE AMOUNT OF BLOOD LOSS WAS NOT AVAILABLE. THE INVESTIGATION HAS YET TO BE COMPLETED. A FOLLOW UP REPORT WILL BE SUBMITTED WHEN THE INVESTIGATION IS COMPLETE BUT NO LATER THAN 30 DAYS FROM THE DATE THAT THIS REPORT WAS SENT. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP. ACTUAL DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 FOR MFG. REPORT NO. 1118880-2015-00088 TO PROVIDE THE SAMPLE EVALUATION RESULTS. THE ACTUAL SAMPLE WAS NOT RETURNED BUT AN UNOPENED AND UNUSED SAMPLE FROM A DIFFERENT PRODUCT/LOT COMBINATION WAS RETURNED TO THE MANUFACTURING FACILITY FOR EVALUATION. THE UNUSED SAMPLE AS WELL AS THE RETENTION SAMPLES FROM THE INVOLVED PRODUCT AND THE SURROUNDING LOTS WERE VISUALLY EXAMINED AND CONFIRMED THERE WERE NO VISUAL DEFECTS. LEAKAGE TESTING REVEALED NO LEAKAGE OF THE DEVICES. A REVIEW OF THE DEVICE HISTORY RECORD OF THE PRODUCT CODE/LOT# COMBINATION WAS CONDUCTED WITH NO RELEVANT FINDINGS. THE USER FACILITY REPORTED TWO DEVICES FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION, ALSO SEE MDR 1118880-2015-00087. THE INVESTIGATION RESULTS VERIFIED THAT THE SEALED RETURN SAMPLE AND RETENTION SAMPLES WERE NORMAL PRODUCT. THE EXACT CAUSE OF THE REPORTED EVENT CANNOT BE DETERMINED. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY ASSURANCE AT THE MANUFACTURING FACILITY FOR APPROPRIATE TRACKING, TRENDING AND FOLLOW-UP.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 1 FOR MFG. REPORT NO. 1118880-2015-00088 TO PROVIDE A STATUS UPDATE ON THE EVALUATION AS WELL AS TO CORRECT THE MDR NUMBER REFERENCED IN THE INITIAL REPORT. THE MDR REFERENCED IN THE INITIAL REPORT WAS AN INCORRECT NUMBER, PLEASE SEE MDR REPORT NUMBER 1118880-2015-00087, THE ORIGINAL REPORT REFERENCED WAS 1118880-2015-00887.

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED VALVE LEAKAGE ON THE RSS602 DEVICE. FOLLOW-UP COMMUNICATION FROM THE USER FACILITY REPORTED THE FOLLOWING INFORMATION: HE PHYSICIAN PUT THE SHEATH IN AND IT STARTED LEAKING THROUGH THE VALVE MORE THAN USUAL; THE DEVICE WAS EXCHANGED FOR A 7FR PINNACLE; THE CASE WENT FINE AND THE PROCEDURE WAS COMPLETED; AND THE PATIENT WAS REPORTED AS DOING FINE. THE USER FACILITY REPORTED TWO DEVICES FROM THE SAME PRODUCT CODE/LOT NUMBER COMBINATION, ALSO SEE MDR 1118880-2015-000887.

    Description of Event or Problem · 1

    THIS REPORT IS BEING SUBMITTED AS FOLLOW UP NO. 2 FOR MFG. REPORT NO. 1118880-2015-00088 TO PROVIDE THE SAMPLE EVALUATION RESULTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    844085 RADIFOCUS INTRODUCER II KIT INTRODUCER CATHETER DYB TERUMO MEDICAL CORPORATION NA TK12

    Patients

    Seq Age Sex Outcome Treatment
    1