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 Difficult To Position (1467)

Patient Problems Blood Loss (2597); Pericardial Effusion (3271)

Event Date 04/30/2014

Event Type  Injury  

Event Description

Information received by medtronic indicated that the patient had a pericardial effusion during a cryoablation procedure.Following difficulty in placing the catheters in the left-sided pulmonary veins, an initial ablation was started.30 seconds into the ablation, it was noted that the arterial line pressure was low.An effusion was identified by ultrasound.Pericardiocentesis was performed and protamine was given to reverse heparin.Two units of blood given and patient's blood pressure stabilized.No further effusion was observed on ultrasound.The cryoablation procedure was cancelled.A ct surgeon was consulted, but there was no need for surgical repair post procedure.Device 1 of 3, reference mfr report: 3002648230-2014-00088 and 3007798852-2014-00009.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.Bin files were reviewed and did not show any system notices for the date of event.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 ; 5146947075
• MDR Report Key: 3838955
• MDR Text Key: 4620254
• Report Number: 3002648230-2014-00087
• 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: 04/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/29/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/01/2014
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 18938
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/25/2013
• 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 (B)(4)
• Patient Outcome(s): Required Intervention
• Patient Age: 00068 YR