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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Tissue Damage (2104); Transient Ischemic Attack (2109); No Code Available (3191)

Event Date 05/13/2019

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/age characteristics is male/65 years old.Of note, multiple patients/multiple manufacturers/multiple methods were noted in the article; however, a one to one correlation could not be made with unique product serial/lot numbers/manufacturer/method.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.A request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: "correlation between asymptomatic gastroesophageal excessive transmural injury after pulmonary vein isolation and a bonus freeze protocol using the second-generation 28-mm cryoballoon for paroxysmal atrial fibrillation." journal of cardiology.(2019) https://doi.Org/10.1016/j.Jjcc.2019.05.008.If information is provided in the future, a supplemental report will be issued.

Event Description

The literature publication reported the following patient complications during the use of a cryoablation catheter: nine (9) patients experienced asymptomatic gastroesophageal excessive transmural injury (eti), which included one (1) with erosion, two (2) with erythema, and six (6) with gastric hypomotility.All signs of gastroesophageal eti resolved approximately one month after their procedure.Temporary phrenic nerve palsy (pnp) occurred with three (3) patients.All three patients fully recovered after three months.One (1) patient experienced a transient ischemic attack.Two (2) patients developed hematomas.The statuses of the balloon catheters and sheaths are unknown.Follow up is being conducted for additional information on the catheters.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: paula bixby ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635055378
• MDR Report Key: 8847986
• MDR Text Key: 152918992
• Report Number: 3002648230-2019-00555
• 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,literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 07/31/2019

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
• Initial Date Manufacturer Received: 07/02/2019
• Initial Date FDA Received: 07/31/2019
• 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): Other