MAUDE Adverse Event Report: HEARTWARE, INC HEARTWARE VENTRICULAR ASSIST SYSTEM; VENTRICULAR (ASSISST) BYPASS

Model Number	1435-
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
One cdc adapter was not returned for evaluation.Review of the manufacturing documentation confirmed that the associated device met all requirements for release.The reported event could not be confirmed since log files were not available for analysis.Analysis of the device could not be performed since the device was not returned for evaluation.Analysis could not be performed as the device was not returned.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.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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the patient noticed damage to dc adapter connector.The damage to the connector prevented a secure connection.The patient discontinued use of the adapter.There were no reported patient consequences associated with the event.No further information was provided.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC; 14400 nw 60th avenue; miami lakes FL 33014 3105
• MDR Report Key: 7047185
• Report Number: 3007042319-2017-04147
• Device Sequence Number: 1851871
• Product Code: DSQ
• UDI-Device Identifier: 00888707000109
• UDI-Public: 00888707000109
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 11/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Model Number: 1435-
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2017
• Initial Report FDA Received Date: 11/20/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 51 YR