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

Model Number 001-700-001S

Device Problems Break (1069); Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon examination of the returned device, it was observed that the distal magnet cap had cracked resulting in the magnet pulling from the distal end of the probe.Failure was confirmed.

Event Description

It was reported that during an af ablation case, the distal plastic tip and magnet broke off the catheter body.The magnet stayed attached to the introducer but the plastic piece holding the magnet fell into the patient's body.The case was delayed and the procedure continued once the parts were retrieved.There was no injury to the patient and no additional medical or surgical intervention was needed.

• Brand Name: COBRA FUSION 150 SURGICAL SYSTEM
• Type of Device: COBRA FUSION 150 SURGICAL SYSTEM
• Manufacturer (Section D): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer (Section G): ATRICURE INC.; 6217 centre park drive; west chester OH 45069 3886
• Manufacturer Contact: ranjana iyer ; 6217 centre park drive; west chester, OH 45069-3886 ; 5137555328
• MDR Report Key: 5443073
• MDR Text Key: 38412567
• Report Number: 3003502395-2016-00004
• Device Sequence Number: 1
• Product Code: OCL
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113475
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial
• Report Date: 01/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 001-700-001S
• Device Catalogue Number: 001-700-001S
• Device Lot Number: 61419
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/19/2016
• 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 Outcome(s): Required Intervention