BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE

    MDR report key: 12497252 · Received September 20, 2021

    Report

    Report Number
    3007042319-2021-06349
    Event Type
    Malfunction
    Date Received
    September 20, 2021
    Date of Event
    September 9, 2021
    Report Date
    November 16, 2021
    Manufacturer
    HEARTWARE, INC.
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR A CORRECTION. B5 WAS CORRECTED TO INDICATE THAT THAT THE CONTROLLER WAS ALSO DROPPED. THE CONTROLLER REMAINS IN USE. H10 CORRECTED TO INCLUDE THE CONTROLLER AS AN ASSOCIATED PRODUCT. ADDITIONAL PRODUCTS: D1: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿CONTROLLER D4: MODEL #: UNK / CATALOG #: UNK / EXPIRATION DATE: UNK / SERIAL OR LOT#: UNK UDI #: ASKU D9: NO H4: MFG DATE: UNK H5: NO H6: PATIENT IME CODE(S): E2403 H6: IMF CODE(S): F26 H6: IMG CODE(S): G04035 H6: FDA DEVICE CODE(S): A051203 H6: FDA RESULTS CODE(S): C21 H6: FDA CONCLUSION CODE(S): D16 INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. 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 · 0

    A SUPPLEMENTAL REPORT IS BEING SUBMITTED FOR DEVICE EVALUATION AND A CORRECTION. H10 SYSTEM REPORTED CONTROLLER WAS CORRECTED TO CONTAIN MODEL #, CATALOG #, EXPIRATION DATE, SERIAL #, UDI #, AND MFG DATE. PRODUCT EVENT SUMMARY: THE DRIVELINE CABLE, ONE CONTROLLER, AND ONE PATIENT PACK WERE NOT RETURNED FOR EVALUATION. A REVIEW OF (B)(6) MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES DID NOT REVEAL ANY VAD DISCONNECT ALARMS OR ANOMALIES LOGGED WITHIN THE ANALYZED PERIOD. ON-SITE INSPECTION OF THE DRIVELINE CABLE, AS WELL AS VISUAL EVIDENCE PROVIDED BY THE SITE REVEALED DAMAGE TO THE STRAIN RELIEF BENEATH A PREVIOUSLY REPAIRED AREA, LEADING TO DAMAGE TO THE OUTER SHEATH BENEATH THE STRAIN RELIEF AND EXPOSED WIRES. THE OBSERVED DAMAGE CORRESPONDS WITH THE REPORTED DROP EVENT. AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. A DRIVELINE SHEATH REPAIR WAS PERFORMED TO MITIGATE THE CONDITIONS REPORTED. THERE IS NO EVIDENCE TO INDICATE THAT A DEVICE MALFUNCTION CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. BASED ON HISTORICAL REVIEW OF SIMILAR EVENTS AND AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE DRIVELINE SHEATH DAMAGE AND DRIVELINE STRAIN RELIEF MAY BE ATTRIBUTED TO THE THE REPORTED DROPPING OF THE PATIENT PACK BY THE PATIENT AND/OR IMPROPER HANDLING. BASED ON THE AVAILABLE INFORMATION, THE MOST LIKELY ROOT CAUSE OF THE REPORTED DROP EVENT CAN BE ATTRIBUTED TO THE HANDLING OF THE DEVICES AS DESCRIBED IN THE EVENT DETAILS. ADDITIONAL PRODUCTS: D4: SERIAL OR LOT#: UNK - PATIENT PACK H6: FDA METHOD CODE(S): B17 H6: FDA RESULTS CODE(S): C20 H6: FDA CONCLUSION CODE(S): D14 D4: MODEL #: 1420 / CATALOG #: 1420 / EXPIRATION DATE: 30-JUN-2021 / SERIAL OR LOT#: (B)(6) UDI #: (B)(4) D9: NO H3: YES H4: MFG DATE:16-JUN-2020 H6: FDA METHOD CODE(S): B15, B17 H6: FDA RESULTS CODE(S): C19 H6: FDA CONCLUSION CODE(S): D14 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.

    Description of Event or Problem · 0

    IT WAS FURTHER REPORTED THAT THE CONTROLLER WAS ALSO DROPPED. THE CONTROLLER REMAINS IN USE.

    Additional Manufacturer Narrative · 1

    INVESTIGATION OF THIS EVENT IS PENDING AND A SUPPLEMENTAL REPORT WILL BE SENT UPON ITS COMPLETION. ADDITIONAL PRODUCTS: BRAND NAME: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿ PATIENT PACK, MODEL #: 1475 / CATALOG #: 1475 / UNK / SERIAL OR LOT#: UNK UDI # (B)(4), DEVICE AVAILABLE FOR EVALUATION: NO, MFG DATE: UNK, LABELED FOR SINGLE USE: (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 THERE WAS DRIVELINE SHEATH DAMAGE, AND BOTH THE DRIVELINE AND DRIVELINE STRAIN RELIEF WERE CRACKED. IT WAS NOTED THAT THE DAMAGE OCCURRED IN A PREVIOUSLY REPAIRED AREA. THE PATIENT BELIEVES THAT THE DAMAGE HAS BEEN MORE GRADUAL AS THEY HAVE DROPPED THEIR PATIENT PACK A COUPLE OF TIMES. SERVICING WAS PERFORMED. THE DRIVELINE AND PATIENT PACK REMAIN 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
    1393779 HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE VENTRICULAR (ASSISST) BYPASS DSQ HEARTWARE, INC. 1103

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Male