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

Model Number CRYO-UNKNOWN

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Stroke/CVA (1770); Transient Ischemic Attack (2109)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender/age of the patients represented in the article is male/59 years old.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique manufacturer/product lot numbers.The model listed in the report is a representative of the model family, as there is no specific model listed.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Referenced article: sivasambu b, balouch ma, zghaib t, et al.Increased rates of atrial fibrillation recurrence following pulmonary vein isolation in overweight and obese patients.J cardiovasc electrophysiol.2018;29:239¿245.Https://doi.Org/10.1111/jce.13388.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications while using a cryoablation balloon catheter: there were three (3) patients who experienced a stroke/transient ischemic attack (tia).There was no treatment/resolution indicated.There were also eight (8) patients who experienced ¿bleeding¿ associated with the procedure.There were 32 patients who had ¿major or minor¿ complications; some of which required medical/surgical intervention and/or prolonged hospitalization.Of note, multiple patients/manufacturers/methods were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The status/location of the cryoballoon catheter is unknown.Further follow up did not yet yield any additional information.No further patient complications have been reported as a result of this event.

• 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: 7426464
• MDR Text Key: 105326151
• Report Number: 3002648230-2018-00218
• 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,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CRYO-UNKNOWN
• Device Catalogue Number: CRYO-UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/21/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 59 YR