MAUDE Adverse Event Report: MEDTRONIC, INC. ACHIEVE MAPPING CATHETER FOR CRYOABLATION; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Patient Problems Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Cardiac Perforation (2513); Pericardial Effusion (3271)

Event Date 11/29/2023

Event Type  Injury  

Event Description

It was reported a patient underwent a cardiac cryo ablation procedure with achieve catheter and patient experienced cardiac perforation treated with a pericardiocentesis.Transseptal puncture performed with baylis wire with fixed curve sheath.The ablation was performed utilizing medtronic cryo.As the procedure continued, it was noted that the patient's blood pressure was hypotensive.Anesthesia performed a co2 which initially was ok, and then the value of the co2 declined and patient was tachycardic.At that point, a bedside echo (ultrasound tte (transthoracic echocardiogram)) was performed on patient and they saw the pericardial effusion.Pericardiocentesis was provided to the patient for medical intervention in the ep (electrophysiology) lab and this stabilized the patient.By the end of the procedure, the patient's condition was improved and he was transferred to icu (intensive care unit).The patient's hospital stay was extended.The patient ultimately had his laa (left atrial appendage) clipped and was discharged two days later.The physician feels the adverse event happened as a result of procedural error.At some point, the laa was perforated, but she is not entirely sure exactly when it happened.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: ACHIEVE MAPPING CATHETER FOR CRYOABLATION
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): MEDTRONIC, INC.
• MDR Report Key: 18419157
• MDR Text Key: 331708937
• Report Number: MW5149666
• 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: Unknown
• Type of Report: Initial
• Report Date: 12/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2023
• Patient Sequence Number: 1