MAUDE Adverse Event Report: ATRICURE, INC. COBRA FUSION 150 MINIMALLY INVASIVE ABLATION

Model Number 001-700-001MI

Device Problems Failure To Adhere Or Bond (1031); Detachment Of Device Component (1104); Device Dislodged or Dislocated (2923)

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

Event Date 07/16/2015

Event Type  malfunction  

Manufacturer Narrative

Complaint # (b)(4).The device was received and sent to atricure engineering for analysis.The complaint was confirmed the magnet was dislodged from the end of the device.

Event Description

It was reported while positioning the fusion probe in the patient the magnet in the introducer located in the distal end became detached.This happened after the first set of ablations it was during the shift change when the fusion was being repositioned.A second introducer set was opened and the procedure was completed successfully.It delayed the procedure for 30 minutes retrieving magnet and repositioning the probe.The patient outcome was not affected.

• Brand Name: COBRA FUSION 150 MINIMALLY INVASIVE ABLATION
• Type of Device: COBRA FUSION 150 MINIMALLY INVASIVE ABLATION
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069 ; 5136444725
• MDR Report Key: 5004151
• MDR Text Key: 23147157
• Report Number: 3003502395-2015-00027
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Not Applicable
• Report Date: 07/17/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/12/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-700-001MI
• Device Lot Number: 14172-052015
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/31/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Age: 65 YR