MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 2AF284

Device Problem Insufficient Information (3190)

Patient Problems Atrial Fibrillation (1729); Atrial Flutter (1730); Cardiac Arrest (1762); Hemorrhage/Bleeding (1888); Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 03/10/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that, during a cryoablation procedure, there was a possible perforation of a cardiac structure resulting in cardiac tamponade.The patient was in atrial fibrillation for the duration of the procedure.The physician gained transseptal access per his routine protocol and the devices were placed in the left atrium.The physician performed 2 ablations in the inferior aspect of the lcpv, 2 ablations in the superior aspect of the lcpv, 2 ablations in the ripv, 2 ablations in the rspv.The patient was alternating between what appeared to be atrial fibrillation and left sided atrial flutter.The decision was made to cardiovert the patient to normal sinus rhythm in order to assess for pulmonary vein potentials.The cryoablation catheter and mapping catheter were pulled back inside of the sheath (confirmed by fluoroscopy), and the patient was cardioverted to normal sinus rhythm.Anesthesia noted the blood pressure to be low (30's systolic) immediately upon cardioversion whereas it had been in the 60's or 70's prior to that point.Chest compressions began and it was noted that the blood pressure was elevated to the 50's as a result of the compressions.An effusion/cardiac tamponade was suspected and a pericardiocentesis tray was opened.Surgery was notified.A pericardiocentesis was performed and no blood was able to be aspirated although an effusion was noted on tee.The ct surgeon performed a sub xyphoid window and placed a drain in the pericardium.It was noted that the drain was drawing off a large volume of blood and the decision was made to put the patient on cardiopulmonary bypass in order to perform a sternotomy allowing surgeon better access to the cardiac structures suspected of perforation (left sided pulmonary vein).As of the day after the complication, the patient was stable and recovering.Device 2 of 3, reference mfr report: 3002648230-2014-00054 and 3007798852-2014-00005.

Manufacturer Narrative

Bin files showed that at least 15 injections were performed with the cryoablation catheter.Failure files did not show any system notices for the date of event.The device is not available for investigation; it was discarded after the procedure.There was no indication of product malfunction.An internal capa has been initiated to investigate the risk of cardiac perforation, pericardial effusion and tamponade associated with cryoablation for atrial fibrillation.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER
• Type of Device: PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: voula radiotis ; 16771 chemin ste-marie; kirkland,qc H9H 5-H3 ; CA H9H 5H3 ; 5146941212
• MDR Report Key: 3716261
• MDR Text Key: 15114066
• Report Number: 3002648230-2014-00055
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/10/2014

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
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2015
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/10/2014
• Initial Date FDA Received: 04/01/2014
• Supplement Dates Manufacturer Received: 03/10/2014
• Supplement Dates FDA Received: 09/14/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/21/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: FLEXCATH ADVANCE 4FC12, ACHIEVE 990063-020
• Patient Outcome(s): Required Intervention
• Patient Age: 00069 YR
• Patient Weight: 79