MAUDE Adverse Event Report: ATRICURE INC. COBRA FUSION 150 ABLATION SYSTEM; COBRA FUSION 150 SURGICAL SYSTEM

Model Number 001-700-003

Device Problems Failure To Adhere Or Bond (1031); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems No Consequences Or Impact To Patient (2199); Foreign Body In Patient (2687)

Event Date 09/09/2015

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 had pulled from proximal magnet housing yoke of the retriever.It was also confirmed that the lexan magnet cap had failed at the pin through hole as well as the 0.005" lip on the distal end of the part leading to the magnet pulling from the probe assembly.

Event Description

While positioning the fusion probe in the patient, the magnet in the introducer's distal end became detached.This happened while the surgeon was positioning the probe prior to performing ablations.Another introducer was opened, and worked fine.During the last ablation, the magnet from the ablation probe detached.This resulted in abortion of the procedure, full ablations were not completed.Both magnets were found.There was no patient harm or intervention required.The case was delayed for 30 minutes.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 60217 centre park drive; west chester OH 45069 3886
• Manufacturer (Section G): ATRICURE, INC; 6217 centre park drive; wst chester OH 45069 3886
• Manufacturer Contact: john huff ; 6217 centre park drive; west chester, OH 45069-3886 ; 5136444125
• MDR Report Key: 5125268
• MDR Text Key: 27420230
• Report Number: 3003502395-2015-00036
• 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: health professional
• Reporter Occupation: Other
• Report Date: 09/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/30/2018
• Device Model Number: 001-700-003
• Device Catalogue Number: 001-700-003
• Device Lot Number: 14172
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/09/2015
• 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 Age: 60 YR