MAUDE Adverse Event Report: MEDTRONIC 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); Cardiac Tamponade (2226)

Event Date 01/19/2016

Event Type  Injury  

Event Description

It was reported that during an afib case, a cardiac tamponade was noticed as the patient's blood pressure dropped.The tamponade was confirmed by ice.A pericardiocentesis was performed and caller reported that approximately 400 ml of fluid were removed.The patient was reported to be in stable condition.The bwi cas reported that it was after the cryo ablation when they noticed the tamponade.Cas also reported that the ablation catheter never entered the patient's body.Smart ablate generator was never used.The procedure was an afib cryo.The only bwi product used was the ultrasound catheter which the physician feels was not involved in the incident.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17531269
• MDR Text Key: 321134793
• Report Number: MW5138184
• 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: 01/22/2016

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