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 Human-Device Interface Problem (2949)

Patient Problem Stenosis (2263)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

Medtronic cryocath 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.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: coronary artery spasm during cryothermal cavotricuspid isthmus ablation.Journal of cardiovascular electrophysiology.2015;26(9):1019-1020.(b)(4).

Event Description

Miyazaki s, ichihara n, takagi t, iesaka y.Coronary artery spasm during cryothermal cavotricuspid isthmus ablation.Journal of cardiovascular electrophysiology.2015;26(9):1019-1020.A journal article was received which contained information regarding this patient's cryoablation procedure.The article stated that one month after the procedure, there was pv stenosis found.The article indicated that this could be explained by the "increased cooling area near the tip of the balloon." no further details were given.No patient complications have been reported as a result of this event.

Manufacturer Narrative

Additional information: this article was found to be previously reported in an individual 3500a regulatory report 3002648230-2014-00223 which was submitted in a timely manner on (b)(6) 2014.

Event Description

Miyazaki s, ichihara n, takagi t, iesaka y.Coronary artery spasm during cryothermal cavotricuspid isthmus ablation.Journal of cardiovascular electrophysiology.2015;26(9):1019-1020.

• 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: 5210893
• MDR Text Key: 30738322
• Report Number: 3002648230-2015-00392
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 10/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2015
• 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?: No
• Date Manufacturer Received: 11/09/2015
• 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): Required Intervention
• Patient Age: 00063 YR