MAUDE Adverse Event Report: DEXTERA SURGICAL INC. CARDICA C-PORT FLEX-A PLUS DISTAL ANASTOMOSIS; CARDIOVASCULAR SURGICAL INSTRUMENTS

Model Number	FG-000150
Medical Device Problem Codes	Fracture (1260); Material Rupture (1546); Defective Component (2292); Failure to Fire (2610)
Health Effect - Clinical Code	Not Applicable (3189)
Date of Event	03/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The c-port xa (fg-000100) and c-port flex-a (fg-000150) share the same design in respect to activation of clamping, deployment, and the energy source used to accomplish these actions.Thus, the same malfunction is noted in the two devices.
Event or Problem Description
The c-port flex-a device was prepared with a vein graft.The pa assisting in the procedure activated the c-port by turning the knob.Upon turning the knob the device broke into pieces that scattered and was accompanied by a loud noise.There was no reported adverse event either to the patient or to user/surgical personnel.

• Brand Name: CARDICA C-PORT FLEX-A PLUS DISTAL ANASTOMOSIS
• Common Device Name: CARDIOVASCULAR SURGICAL INSTRUMENTS
• Manufacturer (Section D): DEXTERA SURGICAL INC.; 900 saginaw dr.; redwood city CA 94063 4753
• MDR Report Key: 7431368
• Report Number: 3004114958-2018-00003
• Device Sequence Number: 1191204
• Product Code: FZP
• UDI-Device Identifier: 11814900001502
• UDI-Public: 0111814900001502
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K073123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 04/13/2018

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: Physician
• Device Expiration Date: 07/02/2019
• Device Model Number: FG-000150
• Device Catalogue Number: FG-000150
• Device Lot Number: 170712A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2018
• Initial Report FDA Received Date: 04/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1