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

Model Number 2AF282

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problems Fistula (1862); Blood Loss (2597)

Event Date 01/01/2016

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.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique product lot numbers.The baseline gender/age of the patients represented in the article is male/61 years old.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: ¿incidence and predictors of complications during cryoballoon pulmonary vein isolation for atrial fibrillation.¿ j am heart assoc.2016;5:e003724 doi: 10.1161/jaha.116.003724.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: there were 49 patients who experienced transient/persistent phrenic nerve injury (pni) during/after the procedure; all of which resolved within 48 days of the procedure.There were three (3) patients who experienced ¿symptomatic pericardial effusion,¿ all of which resolved within seven (7) days.One of these patients did require monitoring overnight in the hospital.There was one patient who presented to the emergency department at six (6) days post-op, with deep ven thrombosis.The patient¿s medications were changed, and at the two-month follow up visit, the symptoms were resolved.There was also one patient who had ¿prolonged bleeding from the groin puncture site.¿ it was found that there was a pseudoaneurysm and arteriovenous fistula that was surgically repaired at day five (5) of post-op.Of note, multiple patients 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/sheath catheter/mapping catheter is unknown.No further patient complications have been reported as a result of this event.

• Brand Name: ARCTIC FRONT 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: 7264389
• MDR Text Key: 99839882
• Report Number: 3002648230-2018-00089
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 02/12/2018

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?: No
• Device Operator: Health Professional
• Device Model Number: 2AF282
• Device Catalogue Number: 2AF282
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/17/2018
• Initial Date FDA Received: 02/12/2018
• 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; Life Threatening; Required Intervention
• Patient Age: 61 YR