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

Model Number	2000US
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
It was reported that the strap tore off of the shower bag.The shower bag was exchanged.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
The shower bag was returned for evaluation.Various analyses were conducted and reviewed to evaluate the performance of the device in relation to the reported event.Failure analysis of the shower bag revealed a damaged strap.As a result, the reported event was confirmed.The most likely root cause of the reported event can be attributed, but not limited, to wear and/or due to the handling of the bag.If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM- SHOULDER BAG
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7764729
• Report Number: 3007042319-2018-03585
• Device Sequence Number: 19167073
• Product Code: DSQ
• UDI-Device Identifier: 00888707000031
• UDI-Public: 00888707000031
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P100047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 12/04/2018

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 Expiration Date: 01/13/2019
• Device Model Number: 2000US
• Device Catalogue Number: 2000US
• Device Lot Number: 1421522
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/25/2018
• Initial Date Received by Manufacturer: 07/12/2018
• Supplement Date Received by Manufacturer: 08/08/2018; 12/03/2018
• Initial Report FDA Received Date: 08/08/2018
• Supplement Report FDA Received Date: 10/03/2018; 12/04/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 1103 VAD
• Patient Age: 11 YR