MAUDE Adverse Event Report: ATRICURE INC. ATRICURE SYNERGY ABLATION SYSTEM; ISOLATOR SYNERGY CLAMP LONG JAW

Model Number OLL2

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

Patient Problems Perforation (2001); Tissue Damage (2104); Blood Loss (2597)

Event Date 11/18/2015

Event Type  Injury  

Manufacturer Narrative

The device was received and sent to atricure engineering for analysis.Upon inspection the device met all criteria and functioned normally.The end effector was inspected under magnification and nothing was noted that may have let to the reported incident.The complaint could not be confirmed.

Event Description

It was reported that during a mvr/tvr/ maze procedure, while positioning the clamp to ablate the left pulmonary veins, the patient's atrium was inadvertently perforated.The surgeon had to patch and suture the hole, a cryo probe was used to complete the maze procedure,.The procedure was prolonged 25-30 minutes.The patient was off pump during the ablations, but was placed on by-pass pump when the surgeon discovered the perforation.The patient was heparinized, but amount is unknown.During a follow-up investigation on (b)(6) 2015, the surgeon stated that the patient is doing great and having no issues.

• Brand Name: ATRICURE SYNERGY ABLATION SYSTEM
• Type of Device: ISOLATOR SYNERGY CLAMP LONG JAW
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069-3886 ; 5136444725
• MDR Report Key: 5308194
• MDR Text Key: 33824854
• Report Number: 3003502395-2015-00048
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100046
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 11/18/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Expiration Date: 05/01/2018
• Device Model Number: OLL2
• Device Catalogue Number: A000362
• Device Lot Number: 58411
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/11/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 81 YR