MAUDE Adverse Event Report: SYNCARDIA SYSTEMS, LLC TAH-T; ARTIFICIAL HEART

Model Number 500101

Device Problem Fracture (1260)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/16/2017

Event Type  malfunction  

Event Description

There was a fracture of the patient's cannula, both sides requiring multiple repairs and required hospitalization of the patient.

• Brand Name: TAH-T
• Type of Device: ARTIFICIAL HEART
• Manufacturer (Section D): SYNCARDIA SYSTEMS, LLC; 1992 east silkverlake rd.; tucson AZ 85713
• MDR Report Key: 6442525
• MDR Text Key: 71150741
• Report Number: 6442525
• Device Sequence Number: 1
• Product Code: LOZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2019
• Device Model Number: 500101
• Device Lot Number: 105679-70CC
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/01/2017
• Device Age: 6 MO
• Event Location: Home
• Date Report to Manufacturer: 03/01/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: MALFUNCTION BREACH OF INTEGRITY OF DRIVELINE THAT