BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0

    MDR report key: 7838221 · Received August 31, 2018

    Report

    Report Number
    3007042319-2018-04189
    Event Type
    Malfunction
    Date Received
    August 31, 2018
    Date of Event
    August 20, 2018
    Report Date
    April 27, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    UDI-DI
    00888707000475
    PMA / PMN Number
    P100047
    Removal / Correction Number
    Z-1336-2021
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT EVENT SUMMARY: TWO CONTROLLERS WERE RETURNED FOR EVALUATION. FAILURE ANALYSIS OF CONTROLLER CON315154 REVEALED A BENT PIN WITHIN POWER PORT ONE OF THE CONTROLLER. THE DAMAGED PIN DID NOT ALLOW A BATTERY TO PROPERLY CONNECT TO THE CONTROLLER. FAILURE ANALYSIS OF CONTROLLER CON315156 REVEALED BENT PINS WITHIN POWER PORTS ONE AND TWO OF THE CONTROLLER. THE DAMAGE DID NOT ALLOW A POWER SOURCE TO PROPERLY CONNECT TO EITHER PORT OF THE CONTROLLER, RENDERING THE CONTROLLER INOPERABLE. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. IN ADDITION, VISUAL INSPECTION UNDER 10X MAGNIFICATION OF CONTROLLER CON315156 REVEALED HAIRLINE CRACKS AROUND POWER PORT TWO. AN INTERNAL INSPECTION DID NOT REVEAL EVIDENCE OF FLUID INGRESS. THE OBSERVED HAIRLINE CRACK IS NOT RELATED TO THE REPORTED EVENT. BASED ON AN INVESTIGATED CONDUCTED, THE ROOT CAUSE OF THE HAIRLINE CRACK(S) WAS DETERMINED TO BE DUE TO CHEMICAL ADDITIVES APPLIED TO THE POWER PORT GASKETS DURING THE MANUFACTURING PROCESS. THE CHEMICAL ADDITIVES CONTRIBUTED TO ENVIRONMENTAL STRESS CRACKING. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE THE HAIRLINE CRACKS THAT HAVE BEEN OBSERVED FOR CONTROLLER 2.0 AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED BENT PINS IN BOTH CONTROLLERS CAN BE ATTRIBUTED TO A MISALIGNMENT BETWEEN THE POWER PORT AND BATTERY OUTPUT CONNECTOR. AN INTERNAL INVESTIGATION HAS BEEN OPENED TO EVALUATE BENT/DAMAGED PINS FOR CONTROLLER 2.0 AND IMPLEMENT CORRECTIVE ACTIONS AS REQUIRED. ADDITIONAL PRODUCTS: CONTROLLER 2.0 CON315156 H3: YES H6 FDA METHOD CODE(S): 10 H6 FDA RESULTS CODE(S): 3243, 180 H6 FDA CONCLUSION CODE(S): 19, 12 MEDTRONIC, INC. (MEDTRONIC) IS SUBMITTING THIS REPORT TO COMPLY WITH 21 C.F.R. PART 803, THE MEDICAL DEVICE REPORTING REGULATION. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION IN THE TIME ALLOTTED AND HAS PROVIDED AS MUCH INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY "DEFECTS" OR HAS "MALFUNCTIONED". THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA, TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REPORTING PURSUANT TO PART 803. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE IT BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR ADDITIONAL INFORMATION. ADDITIONAL INFORMATION WAS RECEIVED REGARDING THE RECALL NUMBER. 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 IS SUBMITTING THIS REPORT TO COMPLY WITH FDA REPORTING REGULATIONS UNDER 21 CFR PARTS 4 AND 803. THIS REPORT IS BASED UPON INFORMATION OBTAINED BY MEDTRONIC, WHICH THE COMPANY MAY NOT HAVE BEEN ABLE TO FULLY INVESTIGATE OR VERIFY PRIOR TO THE DATE THE REPORT WAS REQUIRED BY THE FDA. MEDTRONIC HAS MADE REASONABLE EFFORTS TO OBTAIN MORE COMPLETE INFORMATION AND HAS PROVIDED 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. IN PARTICULAR, THIS REPORT DOES NOT CONSTITUTE AN ADMISSION BY ANYONE THAT THE PRODUCT DESCRIBED IN THIS REPORT HAS ANY ¿DEFECTS¿ OR HAS ¿MALFUNCTIONED¿. THESE WORDS ARE INCLUDED IN THE FDA 3500A FORM AND ARE FIXED ITEMS FOR SELECTION CREATED BY THE FDA TO CATEGORIZE THE TYPE OF EVENT SOLELY FOR THE PURPOSE OF REGULATORY REPORTING. MEDTRONIC OBJECTS TO THE USE OF THESE WORDS AND OTHERS LIKE THEM BECAUSE OF THE LACK OF DEFINITION AND THE CONNOTATIONS IMPLIED BY THESE TERMS. THIS STATEMENT SHOULD BE INCLUDED WITH ANY INFORMATION OR REPORT DISCLOSED TO THE PUBLIC UNDER THE FREEDOM OF INFORMATION ACT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. 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.

    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 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. CONCOMITANT MEDICAL PRODUCTS: HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0; CONTROLLER 2.0 / (B)(4) / MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 2018-10-30, UDI #: (B)(4), RETURN DATE: 2018-08-27 H3: NO, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN, MFG DATE: 2017-10-26. (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A POWER PORT IN THE PATIENT¿S PRIMARY CONTROLLER HAD BENT PINS DUE TO USER ERROR. THE PATIENT WAS AT THE REHAB CENTER AT THE TIME OF THE EVENT. THE CONTROLLER WAS EXCHANGED BY A VENTRICULAR ASSIST DEVICE (VAD) COORDINATOR. THE STAFF AT THE REHAB CENTER WERE RE-TRAINED ON HOW TO CONNECT THE CONTROLLER TO THE POWER SOURCES. IT WAS FURTHER REPORTED THAT THE PATIENT'S BACK UP CONTROLLER ALSO DEVELOPED BENT PINS DUE TO USER ERROR. THE STAFF AND THE PATIENT WERE TRAINED AGAIN ON HOW TO MAKE PROPER CONNECTIONS AND THIS CONTROLLER WAS ALSO EXCHANGED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    678442 HEARTWARE VENTRICULAR ASSIST SYSTEM - CONTROLLER 2.0 VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1420 00888707000475

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR 1103 - VAD