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 Appropriate Term/Code Not Available (3191)

Patient Problems Chest Pain (1776); ST Segment Elevation (2059)

Event Date 01/01/2016

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 ¿ only the abstract was available at the time of this report.This event occurred outside the us.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 abstract: "recurrent and late-onset of coronary spasms after a cryoballoon ablation procedure in a patient with atrial fibrillation." watanbe t., hachiya h., et al.Heart rhythm.2016; 13 (5 suppl.1): s160-s161.

Event Description

"recurrent and late-onset of coronary spasms after a cryoballoon ablation procedure in a patient with atrial fibrillation." watanbe t., hachiya h., et al.Heart rhythm.2016; 13 (5 suppl.1): s160-s161.The literature publication reported the following patient complications: there was one patient who experienced chest pain within 2.5 hours of the cryoballoon ablation procedure.The patient's electrocardiogram showed a "striking st elevation." intervention was done via the "intravenous coronary vasodilator" and the chest pain and st elevation improved.Once the vasodilator was off, again, chest pain occurred and st elevation was seen.The subsequent angiography showed no "organic coronary stenosis." the author concluded that the patient had "recurrent and late-onset of coronary spasms" after the cryoballoon ablation procedure.The status of the cryoballoon is unknown.No further information was provided.No further patient complications have been reported as a result of this event.

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 CRYOCATH LP; 16771 chemin ste-marie; kirkland H9H 5 H3; CA H9H 5H3
• Manufacturer Contact: anne schilling ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635052036
• MDR Report Key: 5778978
• MDR Text Key: 49068623
• Report Number: 3002648230-2016-00266
• 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,Followup
• Report Date: 06/29/2016

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: No Information
• Device Model Number: 2AF284
• Device Catalogue Number: 2AF284
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/29/2016
• Initial Date FDA Received: 07/08/2016
• Supplement Dates Manufacturer Received: 06/29/2016
• Supplement Dates FDA Received: 09/24/2017
• 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: 73 YR