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 Arrhythmia (1721); Exit Block (2628)

Event Date 05/13/2019

Event Type  Injury  

Manufacturer Narrative

Product event summary: the data files were returned and analyzed.The data files showed that at least twelve applications were performed with electrophysiology (ep) catheter, 239f3 with lot number 68906, without any issues on the date of the event.In conclusion, the clinical issues reported could not be confirmed through data analysis.The physical product was not returned for analysis.If information is provided in the future, a supplemental report will be issued.

Event Description

It was reported that during a cryo ablation procedure, the patient went into second and third degree heart block; the patient then went temporarily into tachycardia, then into heart block for an extended period of time.All ablation was stopped and monitoring began.Additionally, it was noted that the mapping system had a reference shift showing the electrophysiology (ep) catheter was not in the expected anatomical location.The case was aborted and the patient was not under general anesthesia.The patient's conduction returned at a later date, and after an extended hospitalization, they were discharged.The patient did not require a pacemaker.No further patient complications have been reported as a result of this event.

• 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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8845171
• MDR Text Key: 152760599
• Report Number: 3002648230-2019-00554
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2021
• Device Model Number: 239F3
• Device Catalogue Number: 239F3
• Device Lot Number: 68906
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/13/2019
• 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