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 Appropriate Term/Code Not Available (3191)

Patient Problem Blood Loss (2597)

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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The baseline gender of the patients represented in the article is male.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: renal function and risk of stroke and bleeding in patients undergoing catheter ablation for atrial fibrillation: comparison between uninterrupted direct oral anticoagulants and warfarin administration.Heart rhythm.2018; 15(3):348-354.10.1016/j.Hrthm.2017.10.033.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 cryoballoon ablation catheter system: there were patients who experienced thromboembolic and/or bleeding events/issues.There was no indication of direct treatment/resolution of said events/issues.According to the article, "the present study aimed to evaluate the safety and efficacy of periprocedural uninterrupted direct oral anticoagulant (doac) use compared with those of uninterrupted warfarin use in patients undergoing catheter ablation for af stratified by various renal function groups." 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 status/location of the ablation 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: 7423522
• MDR Text Key: 105234879
• Report Number: 3002648230-2018-00214
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/19/2018
• 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