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

Model Number FG-000150

Device Problems Retraction Problem (1536); Device Dislodged or Dislocated (2923)

Patient Problems No Known Impact Or Consequence To Patient (2692); Device Embedded In Tissue or Plaque (3165)

Event Date 11/07/2017

Event Type  malfunction  

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 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
• Type of Device: CARDIOVASCULAR SURGICAL INSTRUMENTS
• Manufacturer (Section D): DEXTERA SURGICAL INC.; 900 saginaw dr.; redwood city CA 94063
• Manufacturer (Section G): DEXTERA SURGICAL INC.; 900 saginaw dr.; redwood city CA 94063
• Manufacturer Contact: greg watson ; 900 saginaw dr.; redwood city, CA 94063
• MDR Report Key: 7098161
• MDR Text Key: 94410021
• Report Number: 3004114958-2017-00009
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 11814900001502
• UDI-Public: (01)11814900001502
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K073123
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/10/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/07/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 57 YR