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

Model Number 001-700-003

Device Problem Detachment Of Device Component (1104)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/16/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received but not yet evaluated.When additional information is received a supplemental report will be submitted.

Event Description

It was reported during a mis cardiac tissue ablation procedure, the magnet holder of introducer broke off from the tubing while re-introducing it in to the patient.It fell into the patient.An x-ray was conducted to locate the dislodged piece and then retrieved it.The procedure was prolonged 20 minutes.

Manufacturer Narrative

(b)(4).The complaint was confirmed upon receipt.The magnet housing bond joint to the cable had failed on the introducer.Adhesive was visible around the entire bond joint indicating proper adhesive placement during assembly.

• Brand Name: COBRA FUSION MAGNETIC RETRIEVER SYSTEM
• Type of Device: COBRA FUSION MAGNETIC RETRIEVER 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: 5718430
• MDR Text Key: 47202925
• Report Number: 3003502395-2016-00036
• 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: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup
• Report Date: 05/16/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Model Number: 001-700-003
• Device Catalogue Number: 001-700-003
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/04/2013
• 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