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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Pericardial Effusion (3271)

Event Date 12/12/2016

Event Type  Injury  

Event Description

It was reported that during the stsf aflutter / cryo afib procedure the patient suffered a pericardial effusion.After the flutter ablation with stsf on the right, the cryo catheter was introduced into the left atrium for the afib portion.It was during the afib portion that the patient's blood pressure and o2 saturation decreased dramatically.The effusion was confirmed using ice.They performed a pericardiocentesis and eventually transferred the patient to the or for surgical intervention.The patient's status is unknown.The bwi catheter used was stsf fj, catalog# d134804, lot # unknown, catheter and packaging were unavailable for return.Pi1-16486uw.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ARCTIC FRONT ADVANCE CRYOABLATION CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 17530536
• MDR Text Key: 321070152
• Report Number: MW5137455
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2017

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/12/2023
• Patient Sequence Number: 1