MAUDE Adverse Event Report: ATRICURE INC. COBRA FUSION 150 SURGICAL SYSTEM

Model Number 001-700-001S

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Stroke/CVA (1770)

Event Date 11/08/2016

Event Type  Injury  

Manufacturer Narrative

Cc-2016-870 the device was not returned for evaluation.The lot numbers were obtained for both devices in the case and the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.Device discarded, dhr has been done.

Event Description

Prior to the patient was put on pump, a pvi was performed along with managing the appendage (no clip, cut and sew).From there, the doctor put the patient on pump where he did his ascending repair.After finishing this portion of the procedure he decided to use fusion device to create his roof and floor line.The heart was full when he successfully got the fusion around the oblique and transverse sinus.He confirmed having successful placement and orientation.Physician started the bipolar 1,2,3 sequence and then started the 1,2,3 monopolar sequence successfully, protamine was given.Physician aborted the burn, an act was pulled and more heparin was given.Once close to an act of 250, physician moved forward with finishing the burn sequence and completed the lesion set.Per notification, the patient had a stroke at around 4am the next morning.

• Brand Name: COBRA FUSION 150 SURGICAL SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555328
• MDR Report Key: 6153276
• MDR Text Key: 61697563
• Report Number: 3003502395-2016-00170
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 11/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 13685-101714
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2016
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Removal/Correction Number: 3011706110-09/22/2016/-C
• Patient Sequence Number: 1
• Treatment: OLL2 LOT # 62328
• Patient Outcome(s): Life Threatening; Other
• Patient Age: 85 YR