MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP ARCTIC FRONT ADVANCE CARDIAC CRYOABLATION CATHETER; PERCUTANEOUS CATHETER INTENDED FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problems Hematoma (1884); Nerve Damage (1979); Therapeutic Response, Decreased (2271)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Literature: squara f, zhao a, jauvert g, et al.Comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre european evaluation.Europace.2015;17(5):718-724.Aims whether pulmonary vein isolation (pvi) for paroxysmal atrial fibrillation (paf) using contact force (cf)-guided radiofrequency (rf) or second-generation cryoballoon (cb) present similar efficacy and safety remains uncertain.Methods and results we performed a multicentre study comparing procedural safety and arrhythmia recurrence after standardized pvi catheter ablation for paf using cf-guided rf ablation (thermocool<(><<)>sup>®<(><<)>/sup> smarttouch®, biosense webster; or tacticath®, st jude medical) (cf group) with second-generation cb ablation (arctic front advance®, medtronic) (cb group).Overall, 376 patients (mean age 59.8 ± 10.4 years, 280 males) were enrolled in 4 centres: 198 in cf group and 178 in cb group.Procedure was shorter for cb group than for cf group (109.6 ± 40 vs.122.5 ± 40.7 min, p = 0.003), but fluoroscopy duration and x-ray exposure were not statistically different (p = 0.1 and p = 0.22, respectively).Overall complication rate was similar in both groups: 14 (7.1%) in the cf group vs.13 (7.3%) in the cb group (p = 0.93).However, transient right phrenic nerve palsy occurred only in cb group (10 patients, 5.6%; p = 0.001 vs.Cf group) and severe non-lethal complications (embolic event, tamponade, or oesophageal injury) occurred only in cf group (5 patients, 2.5%;p = 0.03 vs.Cb group).No periprocedural death occurred in either group.Single procedure freedom from any atrial arrhythmias at 18 months post-ablation was comparable in cf group and cb group (76 vs.73.3%, respectively, log rank p = 0.63).Conclusion pulmonary vein isolation using cf-guided rf and second generation cb leads to comparable single-procedure arrhythmia-free survival at up to 18 months with similar overall complication rate.The source literature reported that four (4) patients experienced a groin hematoma.

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.This event occurred outside the us.All information provided is included in this report.Patient information is limited due to confidentiality concerns.The gender of the baseline characteristics is male and the baseline age is (b)(6).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: comparison between radiofrequency with contact force-sensing and second-generation cryoballoon for paroxysmal atrial fibrillation catheter ablation: a multicentre european evaluation.Europace.2015;17(5):718-724.(b)(4).

Manufacturer Narrative

This correction report is being submitted to accurately reflect the complaint information.(b)(4).

• 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: 4888949
• MDR Text Key: 6022923
• Report Number: 3002648230-2015-00172
• 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: Foreign,Literature,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/31/2015

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: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/31/2015
• Initial Date FDA Received: 07/02/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/03/2015
• 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: 00060 YR