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 Device Operates Differently Than Expected (2913)

Patient Problems Hematoma (1884); Pericardial Effusion (3271)

Event Date 03/24/2015

Event Type  Injury  

Event Description

Medtronic received information of a pericardial effusion that occurred during a cryoablation procedure.The arctic front advance catheter was used to isolate the lspv, lipv and rspv and then the transseptal access was lost.The patient was diagnosed with a pericardial effusion following attempt at re-crossing the atrial septum after losing left atrial access.A non-medtronic rf ablation catheter (used for right atrial isthmus ablation for flutter) was advanced through the flexcath advance sheath and across the atrial septum before the pericardial effusion was diagnosed by intracardiac echocardiography.A pericardiocentesis was performed but continuous aspiration of pericardial fluid prompted the physician to call the operating room team.The patient was transferred to the operating room where the chest was opened and, according to the physician, the surgeon observed a hematoma around the right inferior pulmonary vein, but no bleeding.Cryoablation of the right inferior pulmonary vein was not attempted at any point during the procedure.No energy of any kind was applied to the ripv.Device 1 of 2, reference mfr report: 3002648230-2015-00090.

Manufacturer Narrative

The device is not available for investigation; it was discarded after the procedure.There was no indication on catheter malfunction.Bin files were reviewed and showed that at least 11 injections were performed with catheter.

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.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: 4695195
• MDR Text Key: 5640900
• Report Number: 3002648230-2015-00089
• 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: 03/24/2015

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
• Device Lot Number: 07044
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/24/2015
• Initial Date FDA Received: 04/15/2015
• Supplement Dates Manufacturer Received: 03/24/2015
• Supplement Dates FDA Received: 09/18/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/01/2014
• 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 SHEATH, MODEL 4FC12
• Patient Outcome(s): Required Intervention
• Patient Age: 00070 YR