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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Paresis (1998); Vomiting (2144); Discomfort (2330)

Event Date 08/01/2018

Event Type  Injury  

Manufacturer Narrative

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/age characteristic is male/74 years old.Of note, multiple patients were noted in the article; however, a one to one correlation could not be made with unique manufacturer/device serial numbers.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device lot number was provided, it is unknown if this event has been previously reported.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: gastric hypomotility after luminal esophageal temperature guided second-generation cryoballoon pulmonary vein isolation just the tip of the iceberg? journal of circ arrhythm electrophysiol 2018; 11:e006691:1-3.Doi: 10.1161/circep.118.0066.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reports the following patient complications observed two to five days after a cryo ablation procedure: there were a total of three patients who experienced symptomatic gastric hypomotility (gh) or gastroparesis, and exhibited abdominal bloating and repeated vomiting.Additionally, abdominal imaging showed marked gastric dilatation with retained food inside.The patients then subsequently fasted with no oral intake, and were treated with a combination of an antiemetic, provitamin, and macrolide antibiotic.However, gastric endoscopy almost three weeks post treatment still revealed asymptomatic gastric hypomotility.The status and location of the balloon catheters are unknown.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: 8121954
• MDR Text Key: 129017628
• Report Number: 3002648230-2018-00899
• 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: 11/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/01/2018
• 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: 11/12/2018
• 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): Required Intervention
• Patient Age: 74 YR