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

Model Number 700-001S

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

Patient Problem Death (1802)

Event Date 10/03/2016

Event Type  Death  

Manufacturer Narrative

(b)(4) the device was not returned to atricure for evaluation as it was discarded by facility.

Event Description

During a deep-style surgical procedure, the surgeon gained access from the right side of the chest.It was noted that there was fat on the pericardium that was taken off prior to opening the pericardium.Once inside, it was noticed that there were more adhesions than usual and probably due to the multiple endocardial ablations that were performed in the past.Once typical dissection was achieved, dissector was inserted and clamp was placed around right sided pv's.Pv isolation was achieved and confirmed with the max5 pen.At that point, magnetic introducers were inserted and fusion 150 ablation device was pulled in place.Care was taken to make sure the device was below the appendage and nowhere near the circumflex artery.Ten-thousand (10,000) units of heparin was administered and tee probe was pulled back.The fusion device was run for 2 full rounds of bipolar and monopolar at 65c ( 8 minutes per usual).The fusion 150 ablation device was pulled out and the magnets were left in for retrieval on the left side.Mlp1 was utilized to strengthen the points at roof and floor where the fusion line meets up to the pv isolation from the eml2.At that point, a blake drain was inserted and lung brought up, incisions closed and access gained on left side.Magnets retrieved, fusion device hooked up and placed again, 5000 units of heparin was administered and another 8 minute run was performed at 65c.Fusion device and magnets were taken out and mid1 was used to get the eml placed around the pv's.Veins were isolated and confirmed with max5.Mlp1 was used to strengthen the ablation lines at roof/floor/pv junctions and it was also used to ablate from the pv isolation line up onto the laa.A pro235 was inserted and placed on the laa and tee concluded that the appendage was closed.Blake drain inserted and patient converted to nsr.At some point during or directly after procedure, patient suffered a stroke.Patient woke very groggy and had no function of left sided limbs.Magnetic introducer system was left in place on purpose for positioning purposes.Patient expired due to complications of the stroke that was suffered at some point during the procedure or directly after the procedure.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION 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: 6067352
• MDR Text Key: 58769609
• Report Number: 3003502395-2016-00147
• 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
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700-001S
• Device Catalogue Number: 700-001S
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/03/2016
• 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
• Patient Sequence Number: 1
• Treatment: EML2; MAX5; MID1; MLP1; PRO235
• Patient Outcome(s): Death
• Patient Age: 65 YR
• Patient Weight: 113