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 Insufficient Information (3190)

Patient Problems Abdominal Pain (1685); Nausea (1970)

Event Date 08/05/2015

Event Type  Injury  

Manufacturer Narrative

This event occurred outside the us where the same model is distributed.All information provided is included in this report.Patient information is not generally available due to confidentiality concerns.(b)(4).

Event Description

It was reported that the day after a cryo ablation procedure, the patient complained of nausea and gastric discomfort.An x-ray revealed that the patient had a dilated stomach.The patient was transferred to another hospital for specialty care.No further patient complications have been reported as a result of this event.

Manufacturer Narrative

Product event summary: bin files did not show any system notices for the date of procedure.Bin files also showed at least 8 injections were performed with catheter 2af284 / 57264-78.Historical data review showed no occurrences of the reported adverse event for catheter 2af284 with lot #57264.This was a post-procedure clinical event.No product malfunction reported.

Manufacturer Narrative

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

• 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; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer (Section G): MEDTRONIC CARDIAC RHYTHM HEART FAILURE; 8200 coral sea st ne; mounds view MN 55112
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5058269
• MDR Text Key: 25107218
• Report Number: 3002648230-2015-00291
• 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: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Followup
• Report Date: 08/06/2015

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: 05/01/2016
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Device Lot Number: 57264
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: 10/05/2015
• Supplement Dates FDA Received: 09/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2015
• 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: 00068 YR