MAUDE Adverse Event Report: AESDEX, LLC CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM; CLIP

Model Number FG-000001

Device Problem Insufficient Information (3190)

Patient Problem Failure to Anastomose (1028)

Event Date 01/04/2019

Event Type  Injury  

Manufacturer Narrative

An incomplete device was returned with damage to the delivery system noted upon return, which was previously not reported.The user indicated there were no issues with the clip prior to use or any issues during the delivery/anastomosis process.Given the condition of the returned device, a complete investigation was not possible and a conclusion regarding the cause of the event cannot be determined.

Event Description

The device's clip was used to create the proximal anastomosis of a bypass graft during open cardiac bypass surgery.Approximately two hours after creating the anastomosis and prior to completion of the surgery, the graft dislodged from the aorta.While using a pump-oxygenator, the surgeon removed the clip from the graft and sutured the graft to another location.The procedure was completed.

• Brand Name: CARDICA PAS-PORT PROXIMAL ANASTOMOSIS SYSTEM
• Type of Device: CLIP
• Manufacturer (Section D): AESDEX, LLC; 2464 embarcadero way; palo alto CA 94303
• Manufacturer (Section G): AESDEX, LLC; 2464 embarcadero way; palo alto CA 94303
• Manufacturer Contact: todd pope ; 2464 embarcadero way; palo alto, CA 94303 ; 6503317108
• MDR Report Key: 8341327
• MDR Text Key: 136228723
• Report Number: 3004114958-2019-00001
• Device Sequence Number: 1
• Product Code: FZP
• UDI-Device Identifier: 11814900000017
• UDI-Public: 11814900000017
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K091017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 02/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/09/2019
• Device Model Number: FG-000001
• Device Catalogue Number: FG-000001
• Device Lot Number: 180301B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2019
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/15/2019
• Initial Date FDA Received: 02/14/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/27/2018
• 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 Outcome(s): Required Intervention