MAUDE Adverse Event Report: MEDTRONIC ACHIEVE; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 09/24/2018

Event Type  Injury  

Event Description

It was reported that during an afib cryo procedure with medtronic achieve catheter in the left atrial appendage, the patient suffered a cardiac perforation and pericardia i effusion.Additional information was received on 09/28/2018: physician stated that the achieve catheter was responsible for the perforation.(b)(4).This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ACHIEVE
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC
• MDR Report Key: 17521729
• MDR Text Key: 321141984
• Report Number: MW5128677
• Device Sequence Number: 1
• Product Code: DRF
• 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: 10/08/2018

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