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

Model Number OCL

Device Problem Detachment Of Device Component (1104)

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

Event Date 08/30/2016

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 that during a cardiac tissue ablation case, after a full round of ablations on the right side and removing the fusion 150, it was noticed that a magnet from the proximal end of one of the introducers was missing.It had become dislodged from the introducer and was stuck to the tip of the fusion 150.

Manufacturer Narrative

(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.Per the dhr, this lot was built in may & june of 2015 and pre-dates the short term fix per capa (b)(4).The internal surface of the yoke has evidence that uv adhesive was used.The adhesive appears to be inconsistent around the inner diameter of the yoke.All of the other accessories that were returned were intact and passed visual inspection.

• Brand Name: COBRA FUSION 150 ABLATION SYSTEM
• Type of Device: COBRA FUSION 150 ABLATION SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040
• MDR Report Key: 5980800
• MDR Text Key: 55787348
• Report Number: 3003502395-2016-00119
• 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
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/27/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: OCL
• Device Catalogue Number: 700-001S
• Device Lot Number: 13953-022015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/30/2016
• 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: 76 YR