HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0
Report
- Report Number
- 3007042319-2018-00509
- Event Type
- Malfunction
- Date Received
- February 6, 2018
- Date of Event
- December 18, 2017
- Report Date
- October 29, 2018
- Manufacturer
- HEARTWARE, INC.
- Product Code
- DSQ
- PMA / PMN Number
- P100047
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
PRODUCT EVENT SUMMARY: THE RETURNED BATTERIES PASSED EXTERNAL VISUAL INSPECTION AND FUNCTIONAL CHECKS. INVESTIGATION IS ONGOING. ADDITIONAL PRODUCTS: BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 3213 H6 FDA CONCLUSION CODE(S): 25 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 BATTERY (B)(4). H3: YES H6 FDA METHOD CODE(S): 10, 23, 3372, 38 H6 FDA RESULTS CODE(S): 213 H6 FDA CONCLUSION CODE(S): 71 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.
OTHER DEVICES INVOLVED IN THIS EVENT: (B)(4), (B)(4). 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.
PRODUCT EVENT SUMMARY: FIVE BATTERIES (B)(4) WERE RETURNED FOR EVALUATION. THE CONTROLLER (B)(4) WAS NOT RETURNED FOR EVALUATION. A REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT CONTROLLER MET ALL REQUIREMENTS FOR RELEASE. VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE DEVICES IN RELATION TO THE REPORTED EVENT. FAILURE ANALYSIS OF THE RETURNED DEVICES REVEALED THAT THE BATTERIES PASSED VISUAL EXAMINATION AND FUNCTIONAL TESTING. LOG FILE ANALYSIS REVEALED THAT THE CONTROLLER, (B)(4), CONTAINED A SOFTWARE WITH A FEATURE THAT RECORDS WHETHER A POWER SOURCE EXPERIENCED A COMMUNICATION ERROR OR A DISCONNECTION WITHIN EACH 15-MINUTE INTERVAL. ANALYSIS OF DATA FILES REVEALED A POWER SWITCHING EVENT DUE TO MOMENTARY DISCONNECTIONS INVOLVING (B)(4) AND (B)(4), AS WELL AS A POWER SWITCHING EVENT DUE TO A COMMUNICATION ERROR INVOLVING (B)(4). AS A RESULT, THE REPORTED EVENT WAS CONFIRMED. THE MOST LIKELY ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO MOMENTARY DISCONNECTIONS AND COMMUNICATION ERRORS BETWEEN THE CONTROLLER AND BATTERIES. AN INTERNAL INVESTIGATION IS EVALUATING MOMENTARY DISCONNECTIONS. 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.
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. OTHER DEVICES INVOLVED IN THIS EVENT: HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-04-30, RETURN DATE: (B)(6) 2018, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30 , RETURN DATE: (B)(6) 2018, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-04-30 , RETURN DATE: (B)(6) 2018, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-04-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY / (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, RETURN DATE: (B)(6) 2018, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). HEARTWARE VENTRICULAR ASSIST SYSTEM ¿BATTERY/ (B)(4)/ MODEL #: 1650DE / EXPIRATION DATE: 2017-06-30, RETURN DATE: (B)(6) 2018, DEVICE EVALUATION ANTICIPATED, BUT NOT YET BEGUN MFG DATE: 2016-06-30 (B)(4). IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.
IT WAS REPORTED THAT THERE WAS POWER SWITCHING WHEN THE BATTERY CAPACITY WAS GREATER THAN 25 PERCENT. THE BATTERIES WERE REPLACED AND THE CONTROLLER REMAINS IN USE DUE TO MEDICAL CONTRAINDICATION. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 88814 | HEARTWARE VENTRICULAR ASSIST SYSTEM-CONTROLLER 2.0 | VENTRICULAR (ASSISST) BYPASS | DSQ | HEARTWARE, INC. | 1420-MCS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | MCS UNKNOWN VAD |