BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTMATE 3 LVAS MINI APICAL CUFF KIT

    MDR report key: 9526094 · Received December 27, 2019

    Report

    Report Number
    2916596-2019-05977
    Event Type
    Malfunction
    Date Received
    December 27, 2019
    Date of Event
    December 13, 2019
    Report Date
    April 30, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013082
    PMA / PMN Number
    P160054
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    DEVICE EVALUATION: EVALUATION OF THE RETURNED APICAL CUFF HOLDER CONFIRMED THE REPORTED DAMAGE. THE CENTER REPORTED THAT DURING AN IMPLANT, THE APICAL CUFF HOLDER WAS OBSERVED TO BE DAMAGED, OUT OF THE BOX. NO ALARMS WERE REPORTED FOR THIS EVENT. THE SURGEON TAPED THE AREAS THAT WERE BROKEN AND CONTINUED TO USE. THE APICAL CUFF HOLDING TOOL, LOT NUMBER 6822721, WAS RECEIVED FOR EVALUATION ON 26DEC2019. EXAMINATION OF THE RETURNED APICAL CUFF HOLDING TOOL FOUND THAT THE HANDLE WAS CRACKED IN THREE LOCATIONS, APPROXIMATELY 3.25¿, 3.5¿, AND 4.25¿ FROM THE LUER PORT END OF THE TOOL. THE OBSERVED CRACKS EXTENDED APPROXIMATELY HALFWAY THROUGH THE HANDLE DIAMETER. THE OBSERVED DAMAGE APPEARED CONSISTENT WITH BENDING OF THE TOOL. THE DEVICE HISTORY RECORDS FOR THE APICAL CUFF HOLDER LOT NUMBER 6803652 AND APICAL CUFF/TOOL KIT LOT NUMBER 6822721 WERE REVIEWED. NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS WERE OBSERVED. THIS PROCESS INCLUDES VISUAL INSPECTION FOR PHYSICAL DAMAGE AT MULTIPLE STEPS THROUGHOUT THE FABRICATION PROCESS, INCLUDING QA FINAL REVIEW. A DURATION OF TIME FOR WHICH THE APICAL CUFF HOLDING TOOL WAS DAMAGED COULD NOT BE CONCLUSIVELY DETERMINED THROUGH THIS EVALUATION. ADDITIONALLY, THIS ISSUE WAS FORWARDED FOR MANUFACTURING ANALYSIS VIA PI TASK# PI-2019-0266575-01-01-002. A SEPARATE PROCESS QUALIFICATION PREVIOUSLY FOUND THAT MOVING FROM 99.5% IPA TO 70% IPA FOR CLEANING OF THE MACHINED STRAIGHT HANDLE MATERIAL RESULTED IN A LOWER CRACKING RATE OF THAT MATERIAL. A CHANGE WILL BE MADE TO THE APICAL CUFF HOLDING TOOL FABRICATION PROCEDURE SO THAT THE COMPONENTS OF THIS TOOL WILL BE CLEANED WITH 70% IPA BASED ON THE FINDINGS OF THE PREVIOUS REPORT. ALTHOUGH A DURATION OF TIME FOR WHICH THE TOOL WAS DAMAGED COULD NOT BE CONCLUSIVELY DETERMINED, AS AN ADDITIONAL PREVENTIVE MEASURE, THIS FABRICATION PROCEDURE WILL BE REVISED SUCH THAT THE FINAL INSPECTION STEP PRIOR TO SENDING PARTS TO THE CLEANROOM INCLUDES AN INSPECTION FOR PART DAMAGE ALONG WITH THE EXISTING INSPECTION FOR FOREIGN MATERIAL. THESE REVISIONS WILL BE PROCESSED USING CO-018301. PER THE CHANGE ORDER PROCESS, OPERATOR TRAINING WILL TAKE PLACE DURING CO IMPLEMENTATION. THE HM3 MINI APICAL CUFF KIT IFU STATES ¿DO NOT USE THE DEVICE IF IT APPEARS TO BE DAMAGED IN ANY WAY¿. THIS IFU ALSO CONTAINS INSTRUCTIONS FOR PREPARING THE MINI APICAL CUFF AND APICAL CUFF HOLDER, SECURING THE MINI APICAL CUFF TO THE VENTRICLE, AND CONFIRMING HEMOSTASIS. INCIDENTAL FINDINGS: EVALUATION OF THE RETURNED APICAL CUFF HOLDER CONFIRMED THE REPORTED DAMAGE. THE HEARTMATE 3 MINI APICAL CUFF KIT IFU (DOCUMENT #10006218, REV. E) IS CURRENTLY AVAILABLE. THE SURGICAL PROCEDURES SECTION OF THIS IFU STATES ¿DO NOT USE THE DEVICE IF IT APPEARS TO BE DAMAGED IN ANY WAY¿. THIS IFU ALSO CONTAINS INSTRUCTIONS FOR PREPARING THE MINI APICAL CUFF AND APICAL CUFF HOLDER, SECURING THE MINI APICAL CUFF TO THE VENTRICLE, AND CONFIRMING HEMOSTASIS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Additional Manufacturer Narrative · 1

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING IMPLANT THE APICAL CUFF HOLDER WAS OBSERVED TO BE DAMAGED IN 2 SPOTS, OUT OF THE BOX. THE SURGEON TAPED THE AREAS THAT WERE DAMAGED AND CONTINUED TO USE THE HOLDER. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1320353 HEARTMATE 3 LVAS MINI APICAL CUFF KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 10005877 6822721 00813024013082

    Patients

    Seq Age Sex Outcome Treatment
    1