BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP (DRIVELINE CABLE)

    MDR report key: 6292865 · Received February 1, 2017

    Report

    Report Number
    3007042319-2017-00309
    Event Type
    Injury
    Date Received
    February 1, 2017
    Date of Event
    January 9, 2017
    Report Date
    January 11, 2017
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING STROKE, HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. (B)(4) AND A SHOULDER PACK WITH AN UNKNOWN SERIAL NUMBER WERE NOT RETURNED FOR EVALUATION. NO DEVICE MALFUNCTION WAS REPORTED AGAINST (B)(4); THEREFORE, THE PURPOSE OF THIS INVESTIGATION IS SOLELY TO EVALUATE THE DEVICE CONFORMANCE TO INTERNAL RELEASE REQUIREMENTS AND/OR TO IDENTIFY ANOMALIES POTENTIALLY INTRODUCED DURING USE THAT MAY HAVE PREVENTED THE DRIVELINE CABLE FROM PERFORMING AS INTENDED. REVIEW OF THE MANUFACTURING DOCUMENTATION OF (B)(4) CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE MANUFACTURING DOCUMENTATION OF THE SHOULDER PACK COULD NOT BE PERFORMED SINCE THE SERIAL NUMBER IS UNKNOWN. THE REPORTED EVENT WAS CONFIRMED VIA VISUAL EVIDENCE PROVIDED BY THE SITE WHICH REVEALED A BROKEN SHOULDER PACK STRAP. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE BROKEN SHOULDER PACK STRAP MAY BE ATTRIBUTED TO MULTIPLE FACTORS INCLUDING BUT NOT LIMITED TO IMPROPER HANDLING, NORMAL WEAR OVER TIME WHICH CAUSED THE BAG TO FALL TO THE FLOOR EXERTING STRESS ON THE DRIVELINE CABLE THEREBY LEADING TO RUPTURE OF THE DRIVELINE EXIT SITE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISE WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT NOT DIAGNOSIS. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION 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. THE SYSTEM IS DESIGNED TO ASSIST A WEAKENED, POORLY FUNCTIONING LEFT VENTRICLE. THE IMPLANTATION OF A VAD IS AN INVASIVE PROCEDURE REQUIRING GENERAL ANESTHESIA, MEDIAN STERNOTOMY, A VENTILATOR AND CARDIOPULMONARY BYPASS. THESE SURGICAL PROCEDURES ARE ASSOCIATED WITH NUMEROUS RISKS. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING STROKE, HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE. A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT. PRODUCT HAS BEEN NOT RETURNED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED ON 02/03/2017 STATES THAT THERE WAS NO DAMAGE TO THE CONTROLLER OR ALARMS AS A RESULT OF BEING DROPPED. THE PATIENT RECEIVED WOUNDCARE TO THE DRIVELINE EXIT SITE AND CURRENTLY FEELS FINE. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY THE VAD COORDINATOR THAT THE KARABINER BROKE SUDDENLY WITHOUT MANIPULATION. THE BAG FELL ON THE GROUND AND THE DRIVELINE WAS UNDER HEAVY TENSION CAUSING THE DRIVELINE EXIT SITE TO BLEED. THE PATIENT HAD BLEEDING AT THE DRIVELINE EXIT SITE FOR TWO DAYS AND STILL HAS PAIN. THE PATIENT WAS ADMITTED. THE SHOULDER PACK WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75878 HEARTWARE VENTRICULAR ASSIST SYSTEM - PUMP (DRIVELINE CABLE) CIRCULATORY ASSIST SYSTEM, BATTERY DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Hospitalization| L| R UNK SHOULDER PACK