MAUDE Adverse Event Report: ENDOSCOPIC TECHNOLOGIES, AN ATRICURE COMPANY COBRA FUSION 150 ABLATION SYSTEM

Model Number 700-001MI

Device Problem Inadequate or Insufficient Training (1643)

Patient Problem Death (1802)

Event Date 04/15/2014

Event Type  Death  

Event Description

Patient underwent an ablation procedure.The procedure went well and the patient was in sinus rhythm at the end of the procedure.The following morning, the patient had a dense stroke and was found to have a large cerebral hematoma on ct.The patient, during the day, became progressively sicker with cerebral edema and clone.

Manufacturer Narrative

Device history record of all device lots sold to hospital were reviewed - no issues were found.Root cause could not be determined due to the device was not returned.According to discussions during the investigation, the patient may not have been given the proper anti-coagulation medicine.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ENDOSCOPIC TECHNOLOGIES, AN ATRICURE COMPANY; san ramon CA
• Manufacturer Contact: innetta walker ; 2603 camino ramon; ste 100; san ramon, CA 94583 ; 9258667111
• MDR Report Key: 3913385
• MDR Text Key: 21526589
• Report Number: 2953686-2014-00007
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative,Distributor
• Reporter Occupation: Not Applicable
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 06/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 700-001MI
• Device Catalogue Number: 700-001MI-K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Death
• Patient Age: 64 YR