BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE

    MDR report key: 22572366 · Received July 22, 2025

    Report

    Report Number
    3007042319-2025-01499
    Event Type
    Injury
    Date Received
    July 22, 2025
    Date of Event
    July 17, 2025
    Report Date
    August 11, 2025
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707002028
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR INVESTIGATION SUMMARY. PRODUCT EVENT SUMMARY: THE DRIVELINE CABLE ASSOCIATED WITH VENTRICULAR ASSIST DEVICE (B)(6) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF (B)(6) SERVICE HISTORY RECORDS INDICATED THAT THE DEVICE WAS PREVIOUSLY SERVICED AND THE REPAIR ACTIONS WERE VERIFIED. ON-SITE INSPECTION OF. THE DRIVELINE CABLE, AS WELL AS VISUAL EVIDENCE PROVIDED BY THE SITE, REVEALED DAMAGE TO A PREVIOUS DRIVELINE SHEATH REPAIR AND DAMAGE TO THE INNER LUMEN BENEATH THE OUTER SHEATH DAMAGE, LEADING TO EXPOSED AND TWISTED INSULATED CABLE WIRES. ADDITIONALLY, THE VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED EVIDENCE OF A SELF-REPAIR. LOG FILE ANALYSIS REVEALED NO ANOMALIES WITHIN THE ANALYZED PERIOD. AS A RESULT, THE REPORTED EVENTS WERE CONFIRMED. A DRIVELINE SHEATH REPAIR WAS PERFORMED TO MITIGATE THE CONDITIONS REPORTED. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE OBSERVED DRIVELINE REPAIR DAMAGE MAY BE ATTRIBUTED, BUT NOT LIMITED, TO FACTORS SUCH AS NORMAL WEAR OVER TIME AND/OR IMPROPER HANDLING. A POSSIBLE ROOT CAUSE OF THE OBSERVED INNER LUMEN DAMAGE MAY BE ATTRIBUTED TO HANDLING OF THE DEVICE AND/OR WEAR OVER TIME WITHOUT THE OUTER SHEATH PRESENT. THE MOST LIKELY ROOT CAUSE OF THE OBSERVED SELF-REPAIR CAN BE ATTRIBUTED TO THE HANDLING OF THE DEVICE. INVESTIGATION OF THIS EVENT IS COMPLETED AND THE FILE WILL BE CLOSED. IF NEW INFORMATION IS RECEIVED, THE FILE WILL BE RE-OPENED AND A SUPPLEMENTAL WILL BE SUBMITTED. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING NORMAL USE OF THE VENTRICULAR ASSIST DEVICE (VAD), THE DRIVELINE CABLE EXHIBITED SHEATH DAMAGE, EXPOSED WIRES, AND TWISTED WIRES. THE AFFECTED AREA WAS A PREVIOUSLY REPAIRED SECTION. A DRIVELINE SHEATH REPAIR WAS PERFORMED ON TWO OLD REPAIRS APPROXIMATELY 3 AND 10 CM FROM THE STRAIN RELIEF ABOUT 5 CM LONG. OLD TAPE WAS BROKEN AND REMOVED, SECOND PART HAD EXPOSED WIRES, ISOLATION INTACT. THE WIRES WERE UNTWISTED AS MUCH AS POSSIBLE AND TAPE PLACED STARTING FROM THE STRAIN RELIEF APPROXIMATELY 17 CM LONG. THE OPTION OF A SPLICE REPAIR WAS DISCUSSED WITH THE CLINIC AND PATIENT BUT WAS NOT PERFORMED. NO ELECTRICAL FAULTS OR SIGNS OF DRIVELINE (DL) DAMAGE. THE VAD¿S DL REMAINS IN USE. NO PATIENT SYMPTOMS OR COMPLICATIONS WERE ASSOCIATED WITH THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2731391 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP/DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104 00888707002028

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown