MAUDE Adverse Event Report: ATRICURE, INC. LIV SUTURE CATCHER

Model Number 001-340-7475

Device Problems Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 10/08/2014

Event Type  malfunction  

Manufacturer Narrative

Complaint number (b)(4) upon inspection the complaint was confirmed upon receipt.The piece that broke off the device was not returned.Unrelated to this complaint, the device did not have a serial number etched per print 635-13513.D.

Event Description

During a mitral valve repair, the tip broke off of the device.

• Brand Name: LIV SUTURE CATCHER
• Type of Device: LIV SUTURE CATCHER
• Manufacturer (Section D): ATRICURE, INC.; 7555 innovation way; mason OH 45040
• Manufacturer Contact: ranjana iyer ; 7555 innovation way; mason, OH 45040 ; 5137555320
• MDR Report Key: 6064477
• MDR Text Key: 58719454
• Report Number: 3003502395-2016-00140
• Device Sequence Number: 1
• Product Code: DWS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/19/2016

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: 001-340-7475
• Device Catalogue Number: 001-340-7475
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/19/2016
• Initial Date FDA Received: 10/28/2016
• 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: Reuse
• Patient Sequence Number: 1