MAUDE Adverse Event Report: ATRICURE, INC CYRO LINEAR PROBE; SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number INSS0008610

Device Problem Explosion (4006)

Patient Problem Insufficient Information (4580)

Event Date 02/08/2022

Event Type  malfunction  

Event Description

The linear cryo probe exploded while using it during maze procedure.

• Brand Name: CYRO LINEAR PROBE
• Type of Device: SURGICAL CARDIAC ABLATION DEVICE, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): ATRICURE, INC; 7555 innovation way; mason OH 45040
• MDR Report Key: 13886844
• MDR Text Key: 287820318
• Report Number: 13886844
• Device Sequence Number: 1
• Product Code: OCM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: INSS0008610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/15/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2022
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27375 DA
• Patient Sex: Male
• Patient Weight: 88 KG