MAUDE Adverse Event Report: ATRICURE, INC. ATRICURE BIPOLAR SYSTEM

Model Number ATRICURE RF ABLATION CLAMP (UNKNOWN)

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

Patient Problems Nerve Damage (1979); Pulmonary Valve Stenosis (2024)

Event Date 06/10/2017

Event Type  Injury  

Manufacturer Narrative

(b)(4) - there was no device malfunction reported, information obtained was from a poster presentation.

Event Description

There was a poster presentation at (b)(6) 2017, from the (b)(6) hospital, on the minimally invasive procedure for patients in longstanding persistent af.In their study, they reported 3 cases of pulmonary vein stenosis associated with solation of the pvs with the bipolar clamp and 2 cases of phrenic nerve palsy.There was no device malfunction reported.

• Brand Name: ATRICURE BIPOLAR SYSTEM
• Type of Device: ATRICURE BIPOLAR SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer (Section G): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: anupam bedi
• MDR Report Key: 6694524
• MDR Text Key: 79353140
• Report Number: 3011706110-2017-00061
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K101174
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ATRICURE RF ABLATION CLAMP (UNKNOWN)
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/10/2017
• 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
• Patient Outcome(s): Disability