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 Problem Nerve Damage (1979)

Event Date 08/01/2015

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.The baseline gender/age is male/63 years old.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: acute and long-term outcomes of catheter ablation of atrial fibrillation using the second-generation cryoballoon versus open-irrigated radiofrequency: a multicenter experience.Journal of cardiovascular electrophysiology.2015;26(8):832-839.(b)(4).

Event Description

Aryana amsmdf, bowers mr, o'neill pg, et al.Acute and long-term outcomes of catheter ablation of atrial fibrillation using the seco nd-generation cryoballoon versus open-irrigated radiofrequency: a multicenter experience.Journal of cardiovascular electrophysiology.2015;26(8):832-839.Second-generation cryoballoon versus rf introduction there are limited comparative data on catheter ablation of atrial fibrillation (caaf) using the second-generation cryoballoon (cb-2) versus point-by-point radiofrequency (rf).This study examines the acute/long-term caaf outcomes using these 2 strategies.Methods and results in this multicenter, retrospective, nonrandomized analysis, procedural and clinical outcomes of 1,196 patients (76% with paroxysmal af) undergoing caaf using cb-2 (n = 773) and open-irrigated, non-force sensing rf (n = 423) were evaluated.Pulmonary vein isolation was achieved in 98% with cb-2 and 99% with rf (p = 0.168).Cb-2 was associated with shorter ablation time (40± 14 min vs.66 ± 26 min; p <(><<)> 0.001) and procedure time (145 ± 49 minutes vs.188 ± 42 minutes; p <(><<)> 0.001), but greater fluoroscopic utilization (29 ± 13 minutes vs.23 ± 14 minutes; p <(><<)> 0.001).While transient (7.6% vs.0%; p <(><<)> 0.001) and persistent (1.2% vs.0%; p = 0.026) phrenic nerve palsy occurred exclusively with cb-2, other adverse event rates were similar between cb-2 (1.6%) and rf (2.6%); p = 0.207.However, freedom from af/atrial flutter/tachycardia at 12 months following a single procedure without antiarrhythmic therapy was greater with cb-2 (76.6%) versus rf (60.4%); p <(><<)> 0.001.While this difference was evident in patients with paroxysmal af (p <(><<)> 0.001), it did not reach significance in those with persistent af (p = 0.089).Additionally, cb-2 was associated with reduced long-term need for antiarrhythmic therapy (16.7% vs.22.0%; p = 0.024) and repeat ablations (14.6% vs.24.1%; p <(><<)> 0.001).Conclusion in this multicenter, retrospective, nonrandomized study, caaf using cb-2 coupled with rf as occasionally required was associated with greater freedom from atrial arrhythmias at 12 months following a single procedure without antiarrhythmic therapy when compared to open-irrigated, non-force sensing rf, alone.The literature publication reports the following patient complications: gastroparesis.

• 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: 5095729
• MDR Text Key: 26478722
• Report Number: 3002648230-2015-00307
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P100010/S015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Report Date: 09/08/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/22/2015
• 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?: Yes
• Date Manufacturer Received: 09/08/2015
• 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 Age: 00063 YR