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

Model Number 001-700-003

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 08/03/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for eval.Pursuant to atricure's internal processes, the complaint was escalated to a level ii investigation.During the investigation, the device history record for lot 13734-111214 was reviewed for non-conformance reports and reworks, none were found that related to this defect.All 83 devices from this lot passed their 100% inspecting, which includes verifying that the magnet is present and secure.An investigation of this failure mode determined that insufficient adhesive can allow the magnet to become dislodge, therefore, capa (b)(4) was imitated to improve the adhesive application process.

Event Description

It was reported during a minimally invasive procedure, that the magnet became dislodged from the tip of the magnetic retriever.The dislodged magnet was found attached to the tip of the partner magnet, and was therefore retrieved without issue.The facility re-glued the magnet using their own adhesive, prolonging the procedure five minutes.The pt outcome was not affected.

• Brand Name: COBRA FUSION MAGNETIC RETRIEVER SYSTEM
• Type of Device: COBRA FUSION MAGNETIC RETRIEVER SYSTEM
• Manufacturer (Section D): ATRICURE, INC.; west chester OH
• Manufacturer Contact: john huff ; 6217 centre park dr. ; west chester, OH 45069 ; 5136444725
• MDR Report Key: 5048838
• MDR Text Key: 24920126
• Report Number: 3003502395-2015-00031
• 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: Not Applicable
• Report Date: 08/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-700-003
• Device Catalogue Number: 700-003
• Device Lot Number: 13734-111214
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/03/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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