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

Model Number	1318
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	01/30/2018
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 while using a tunneling rod to tunnel through the patient¿s abdomen, the rod was bent by the surgeon and it snapped in half.The surgeon was able to feed the rod through the patient¿s abdomen to connect the driveline and successfully pulled the driveline through the patient¿s abdomen.A provided picture appears to confirm the reported break.The device was removed from service.No patient complications have been reported as a result of this event.
Additional Manufacturer Narrative
The tunneling rod was not returned for evaluation.Visual evidence provided by the site revealed damage to the tunneled rod.The rod exhibited a break through the center.As a result, the reported event was confirmed.There is no evidence to suggest that a device malfunction caused or contributed to the reported event.Of note, it was reported by the site that the operating surgeon bent the tunneling rod while tunneling the driveline through the patient's abdomen, at which point the tool broke.Based on the available information, the most likely root cause of the reported event can be attributed to handling of the device.If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: HEARTWARE VENTRICULAR ASSIST SYSTEM - TUNNELING ROD
• Common Device Name: VENTRICULAR (ASSISST) BYPASS
• Manufacturer (Section D): HEARTWARE, INC.; 14400 nw 60th ave; miami lakes FL 33014
• MDR Report Key: 7296314
• Report Number: 3007042319-2018-00815
• Device Sequence Number: 1236926
• Product Code: DSQ
• UDI-Device Identifier: 00888707000154
• UDI-Public: 00888707000154
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/27/2018

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: Health Professional
• Device Expiration Date: 06/30/2019
• Device Model Number: 1318
• Device Catalogue Number: 1318
• Device Lot Number: 1307763
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2018
• Supplement Date Received by Manufacturer: 02/26/2018; 09/25/2018
• Initial Report FDA Received Date: 02/26/2018
• Supplement Report FDA Received Date: 02/26/2018; 09/27/2018
• 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: 55 YR
• Patient Weight: 53