MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FREEZOR MAX CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 239F3

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Chest Pain (1776); Pericardial Effusion (3271)

Event Date 01/07/2019

Event Type  Injury  

Manufacturer Narrative

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

Event Description

It was reported that following a cryo ablation procedure that was completed with cryo, the patient experienced chest pain, and a pericardial effusion was noted.It was noted that during the procedure, an electrophysiology (ep) catheter was used to create a cavo-tricuspid isthmus (cti) block line.The patient's hospitalization was extended.The patient is noted to be stable at this time.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least 8 applications were performed with balloon catheter, 2af284 with lot number 06419, and 9 applications with electrophysiology catheter, 239f3 with lot number 59484, without any issue on the date of the event.Clinical issues were encountered during the case.The electrophysiology catheter was not returned for investigation.There is no indication of a product malfunction related to the adverse event.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FREEZOR MAX 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: lisa robertson ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635262723
• MDR Report Key: 8355991
• MDR Text Key: 136720949
• Report Number: 3002648230-2019-00128
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/21/2019

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: 01/25/2020
• Device Model Number: 239F3
• Device Catalogue Number: 239F3
• Device Lot Number: 59484
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/28/2019
• Initial Date FDA Received: 02/20/2019
• Supplement Dates Manufacturer Received: 02/21/2019
• Supplement Dates FDA Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/25/2018
• 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): Hospitalization
• Patient Age: 71 YR