MAUDE Adverse Event Report: DEXTERA SURGICAL INC. CARDICA C-PORT XA PLUS ANASTOMOSIS SYSTEM; CARDIOVASCULAR SURGICAL INSTRUMENTS

Model Number FG-000100

Device Problems Fracture (1260); Material Rupture (1546); Defective Component (2292); Failure to Fire (2610)

Patient Problem Not Applicable (3189)

Event Date 03/07/2018

Event Type  malfunction  

Manufacturer Narrative

The c-port xa (fg-000100) and c-port flexa (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.Corrected data: device problem codes were added.

Event Description

The c-port device was removed from the packaging by the technician and passed to the surgeon to prepare.The graft was loaded onto the device and the device was activated.When the deployment button was pushed, the device did not deploy.The device was then removed from the surgical field and placed on a non-sterile back table.Approximately 10 to 15 minutes later,the device broke into pieces while on the non-sterile back table, accompanied by a loud noise.There was no reported adverse event either to the patient or to surgical personnel.

• Brand Name: CARDICA C-PORT XA PLUS ANASTOMOSIS SYSTEM
• 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: adam shively ; 900 saginaw dr.,; redwood city, CA 94063 ; 6503317152
• MDR Report Key: 8356548
• MDR Text Key: 137445976
• Report Number: 3004114958-2018-00001
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 1184900001007
• UDI-Public: (01)1184900001007
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 04/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2019
• Device Model Number: FG-000100
• Device Catalogue Number: FG-000100
• Device Lot Number: 171012A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/07/2017
• 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