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

Model Number 001-700-0015

Device Problem Detachment Of Device Component (1104)

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

Event Date 10/28/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was not returned for evaluation, however, the device history record was reviewed and no non-conformance or reworks were noted during the manufacturing process that relate to the reported issue.Device discarded by facility.

Event Description

It was reported by the sales representative, during an mia ablation, the magnet fell out of the device and connected to the introducer and did not fall into the patient.The facility glued the magnet back in.There was no patient harm or delay in the case.

• Brand Name: COBRA FUSION 150 ABLATION MINIMALLY INVASIVE SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chest, OH 45069-3886
• MDR Report Key: 5798795
• MDR Text Key: 49754599
• Report Number: 3003502395-2016-00039
• 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
• Report Date: 10/28/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-700-0015
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/28/2015
• Initial Date FDA Received: 07/15/2016
• Was Device Evaluated by Manufacturer?: No
• 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: 71 YR
• Patient Weight: 88