BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TITAN STABILIZER ATTACHMENT

    MDR report key: 9679645 · Received February 6, 2020

    Report

    Report Number
    1124841-2020-00021
    Event Type
    Injury
    Date Received
    February 6, 2020
    Date of Event
    January 16, 2020
    Report Date
    March 13, 2020
    Manufacturer
    TERUMO CARDIOVASCULAR SYSTEMS CORPORATION
    Product Code
    MWS
    UDI-DI
    00699753450554
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H6 (IDENTIFICATION OF EVALUATION CODES 10, 11, 3331, 3259, 12). METHOD CODE #1: 10 - TESTING OF ACTUAL/SUSPECTED DEVICE. METHOD CODE #2: 11 - TESTING OF DEVICE FROM SAME LOT/BATCH RETAINED BY MANUFACTURER. METHOD CODE #3: 3331 - ANALYSIS OF PRODUCTION RECORDS. RESULTS CODE: 3259 - IMPROPER PHYSICAL STRUCTURE. CONCLUSIONS CODE: 12 - CAUSE TRACED TO DEVICE DESIGN. THE AFFECTED SAMPLE WAS INSPECTED AND OBSERVED THAT THE U SHAPED TUBE WAS BROKEN WITHIN THE AREA OF THE SILICONE FOOT. THE REMAINING METAL TUBE WAS REMOVED FROM THE SILICONE FOOT WHERE IT WAS OBSERVED THAT THE TUBE WAS BENT. THE TUBE WAS MEASURED AS .070" OD, THIS IS WITHIN DESIGN SPECIFICATION. THE U-TUBE IS MEANT TO BE BENT, HOWEVER, BENDING PAST DESIGN SPECIFICATION CAN LEAD TO BREAKAGE. A REPRESENTATIVE RETENTION SAMPLE WAS EVALUATED. THE U SHAPED TUBE WAS MEASURED AT VARIOUS POINTS BETWEEN .070" - .072", THIS IS WITHIN DESIGN SPECIFICATION. THE DESIGN CRITERIA FOR THE U SHAPED TUBE IS THAT IT MUST BE ABLE TO WITHSTAND 3 BENDING CYCLES OF +45* TO -20*. THE RETENTION WAS BENT IN THIS WAY AND DID NOT BREAK. ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS SUBMITTED TO FDA IN ACCORD WITH APPLICABLE REGULATIONS ¿ AND AS INDICATED BY TERUMO CARDIOVASCULAR SYSTEMS IN THE INITIAL REPORT SUBMITTED TO THE FDA ON FEBRUARY 6, 2020. UPON FURTHER INVESTIGATION OF THE REPORTED EVENT, THE FOLLOWING INFORMATION IS NEW AND/OR CHANGED: H3 (DEVICE EVALUATION ANTICIPATED BY MANUFACTURER - A SECOND FOLLOW-UP WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION AND/OR SUBMISSION OF NEW INFORMATION, THUS TCVS REFERENCES CONCLUSIONS CODE 11.) . ALL AVAILABLE INFORMATION HAS BEEN PLACED ON FILE IN QUALITY MANAGEMENT FOR APPROPRIATE TRACKING, TRENDING, AND FOLLOW-UP.

    Additional Manufacturer Narrative · 1

    TERUMO HAS NOT RECEIVED THE DEVICE FOR EVALUATION; THEREFORE, THE INVESTIGATION HAS YET TO BE COMPLETED. TERUMO PLANS ON SUBMITTING A FOLLOW-UP REPORT WHEN THE INVESTIGATION IS COMPLETE AND WHEN MORE INFORMATION BECOMES AVAILABLE. (B)(4).

    Description of Event or Problem · 1

    THE USER FACILITY REPORTED TO TERUMO CARDIOVASCULAR THAT DURING CARDIOPULMONARY BYPASS, WHILE USING THE TITAN STABILIZER, THE RIGHT METAL WISHBONE PART OF THE FOOTPLATE RUBBED A HOLE IN THE HEART. A HEMOSTATIC AGENT WAS USED TO STOP THE BLEEDING. THERE WAS APPROXIMATELY 100 ML OF BLOOD LOSS, THERE WAS MINIMAL DELAY, THE PRODUCT WAS NOT CHANGED OUT, THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    140625 TITAN STABILIZER ATTACHMENT UNIVERSAL STABILIZER ARM MWS TERUMO CARDIOVASCULAR SYSTEMS CORPORATION T401231 00107 00699753450554

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R