BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE CABLE

    MDR report key: 7144604 · Received December 22, 2017

    Report

    Report Number
    3007042319-2017-05451
    Event Type
    Malfunction
    Date Received
    December 22, 2017
    Date of Event
    August 3, 2015
    Report Date
    December 22, 2017
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1751-2015
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT EVENT SUMMARY: DRIVELINE CABLE HW(B)(4) WAS NOT RETURNED FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DRIVELINE CABLE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES ASSOCIATED WITH THE EVENT SHOWED PARAMETERS TO BE WITHIN NORMAL OPERATION. ON-SITE INSPECTION OF THE DRIVELINE CABLE REVEALED MULTIPLE BREAKS IN THE OUTER SHEATH, CONFIRMING THE REPORTED EVENT. ADDITIONALLY, VISUAL EVIDENCE PROVIDED REVEALED YELLOWING OF THE DRIVELINE CABLE. THE PREVIOUS REPAIR WAS REMOVED AND A DRIVELINE SHEATH REPAIR WAS PERFORMED TO MITIGATE THE CONDITIONS REPORTED. AN INTERNAL INVESTIGATION EVALUATED DRIVELINE SHEATH DAMAGES. BASED ON THE INVESTIGATION CONDUCTED, THE MOST LIKELY ROOT CAUSE OF THE DRIVELINE SHEATH DAMAGE IS EXPOSURE TO UV LIGHT. THIS EVENT WAS ASSESSED AND IS BEING REPORTED AS PART OF A RETROSPECTIVE REVIEW OF EVENTS, WHICH WAS IN RESPONSE TO AN UPDATE TO THE MDR DECISION CRITERIA. THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION AND DESTINATION THERAPY IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS. A GOOD FAITH EFFORT WILL BE MADE TO OBTAIN THE APPLICABLE INFORMATION RELEVANT TO THE REPORT. IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE OUTER SHEATH BREAKS. MULTIPLE SMALL BREAKS OF THE OUTER SHEATH STARTING FROM THE STRAIN RELIEF UP TO ABOUT FIFTEEN CENTIMETER FROM THE EXIT SITE. OUTER SHEATH YELLOWISH COLORED. A DRIVELINE SHEATH REPAIR WAS COMPLETED. THERE WAS NO REPORTED EFFECT ON THE PATIENT. THE DRIVELINE REMAINS IN USE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    923191 HEARTWARE VENTRICULAR ASSIST SYSTEM-DRIVELINE CABLE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1104

    Patients

    Seq Age Sex Outcome Treatment
    1