MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION MAGNETIC RETREIVER SYSTEM

Model Number 001-700-003

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/20/2016

Event Type  malfunction  

Manufacturer Narrative

Complaint number (b)(4).The device has not yet been returned to atricure for evaluation.If additional information is received a supplemental report will be submitted.The device history record was reviewed and no non-conformances or re-works were noted during manufacturing process that would be related to the reported issue.Not returned to manufacturer.

Event Description

During a surgical case with the fusion device, the magnet from the tip of magnetic introducer got detached.The procedure was prolonged five minutes and case was completed.The patient was off pump and their outcome was not affected.

• Brand Name: COBRA FUSION MAGNETIC RETREIVER SYSTEM
• Type of Device: COBRA FUSION MAGNETIC RETREIVER SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555320
• MDR Report Key: 5689644
• MDR Text Key: 46257387
• Report Number: 3003502395-2016-00026
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K113475
• 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: 05/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2018
• Device Model Number: 001-700-003
• Device Catalogue Number: 001-700-003
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/03/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/22/2015
• 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): Required Intervention