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

Model Number 2AF283

Device Problem Kinked (1339)

Patient Problems Hypoxia (1918); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 10/25/2017

Event Type  malfunction  

Manufacturer Narrative

Product event summary: the data files and balloon catheter 2af283, with lot number 89218 were returned and analyzed.The data files showed at least 14 applications were performed with the balloon catheter on the date of the event and did not show any issues.Visual inspection of the balloon catheter showed the push button luer was broken.The luer broke outside the patient¿s body and does not relate to the clinical issues.The catheter passed the performance test and electrical integrity as per specification; impedance was also within specification.Furthermore, dissection showed a guide wire lumen kink inside the balloon at 1.45 inches from the tip of the catheter.Several clinical issues (cardiac tamponade, pericardial effusion, hypoxia and hypotension) were encountered during the procedure.There is insufficient evidence to conclude that the malfunctions are related to the clinical issues.

Event Description

It was reported that during a cryo ablation procedure, systolic and diastolic pressures were out of the expected range, and oxygen through the pulsiometer were low.A transthoracic echography was performed and a tamponade was observed.Pericardiocentesis was performed.Medication was administered which controlled the blood effusion.Blood was transfused.The patient stabilized.It was noted that the tamponade occurred when the sheath was moved from the right side to the left side.The case was completed with cryo.No further patient complications have been reported as a result of this event.The balloon catheter subsequently tested out of specification per the manufacturer's investigation.

Manufacturer Narrative

Product event summary: not able to disassociate or associate the malfunction from the adverse event.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; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer (Section G): MEDTRONIC CRYOCATH LP; 9000 autoroute transcanadienne; pointe-claire,qc H9R 5 Z8; CA H9R 5Z8
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 7201749
• MDR Text Key: 97895021
• Report Number: 3002648230-2018-00041
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/08/2018
• Device Model Number: 2AF283
• Device Catalogue Number: 2AF283
• Device Lot Number: 89218
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/28/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/19/2017
• Initial Date FDA Received: 01/17/2018
• Supplement Dates Manufacturer Received: 12/19/2017
• Supplement Dates FDA Received: 01/19/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/08/2016
• 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
• Patient Outcome(s): Life Threatening; Required Intervention