MAUDE Adverse Event Report: MEDTRONIC, INC. ARCTIC FRONT ADVANCE; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

Device Problem Material Rupture (1546)

Patient Problem No Information (3190)

Event Date 05/15/2017

Event Type  malfunction  

Event Description

During a-fib ablation procedure, inner balloon ruptured when inflated.Several successful inflations had already been completed when balloon ruptured.Manufacturer response for cryocath balloon, arctic front advance (per site reporter).Picked up device.

• Brand Name: ARCTIC FRONT ADVANCE
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.; 8200 coral sea street ne; mounds view MN 55112
• MDR Report Key: 6618042
• MDR Text Key: 76848467
• Report Number: 6618042
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 02/22/2018
• Device Model Number: 2AF284
• Device Lot Number: 81279
• Other Device ID Number: 1363289
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/23/2017
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 57 YR