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	Retraction Problem (1536); Device Dislodged or Dislocated (2923)
Health Effect - Clinical Codes	No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)
Date of Event	11/07/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was retained by the user facility and was not returned to the manufacturer for evaluation.Poor quality photographs of the device were obtained which did not allow an adequate investigation of the device.In discussion with the surgeon performing the procedure, the procedure was completed as intended and the device functioned properly.The surgeon believes the metallic component (spring) was caught on the trocar during removal of the device and does not recommend another procedure to recover the component.The surgeon does not believe this was a device performance issue but rather use error.
Event or Problem Description
The patient underwent a robotic tecab procedure in which the c-port device was used to perform the distal bypass anastomosis.The device functioned as intended and the procedure was completed as intended.Following a post-operative chest x-ray, a small metallic density was noted in the patient's left chest that was previously not recognized.After surgery, the patient was transferred for normal postoperative care.No patient complications have been reported as a result of the metallic density.

• 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
• MDR Report Key: 7098161
• Report Number: 3004114958-2017-00009
• Device Sequence Number: 900464
• Product Code: FZP
• UDI-Device Identifier: 11814900001502
• UDI-Public: (01)11814900001502
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K073123
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 12/07/2017

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: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: FG-000150
• Device Catalogue Number: FG-000150
• Device Lot Number: 170712A-045
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/10/2017
• Initial Report FDA Received Date: 12/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR