MAUDE Adverse Event Report: MEDTRONIC CRYOCATH LP FLEXCATH STEERABLE SHEATH; CATHETER, STEERABLE

Model Number 4FC12

Device Problem Device Operates Differently Than Expected (2913)

Patient Problems Unspecified Infection (1930); Pseudoaneurysm (2605)

Event Date 12/01/2015

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.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 approximately 56 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: point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the cryo versus rf trial).Journal of cardiovascular electrophysiology.2015;26(12):1307-1314.(b)(4).

Event Description

Hunter rj, baker v, finlay mc, et al.Point-by-point radiofrequency ablation versus the cryoballoon or a novel combined approach: a randomized trial comparing 3 methods of pulmonary vein isolation for paroxysmal atrial fibrillation (the cryo versus rf trial).Journal of cardiovascular electrophysiology.2015;26(12):1307-1314.The cryo versus rf trial introduction catheter ablation of paroxysmal af using the cryoballoon (cryo) has yielded similar success rates to conventional wide encirclement using radiofrequency catheter ablation (rfca), but randomized data are lacking.Pilot data suggested a high success rate with a combined approach (combined) using wide encirclement with rfca followed by 2 cryo applications to each vein.We compared these 3 strategies in a randomized controlled trial.Methods and results patients undergoing first time paroxysmal af ablation were randomized to rfca, cryo, or combined.Patients were followed up at 3, 6, and 12 months with 7 days of ambulatory ecg monitoring.Success was defined as freedom from arrhythmia without antiarrhythmic drugs after a single procedure.A total of 237 patients were randomized.Success at 1 year was achieved in 47% in the rfca group, 67% in the cryo group, and 76% in the combined group (p <(><<)> 0.001 for rfca vs.Cryo, p<(><<)> 0.001 for rfca vs.Combined, rfca vs.Cryo, and cryo vs.Combined groups).Conclusions pulmonary vein isolation for paroxysmal af is faster with cryo and results in a higher single procedure success rate than conventional point by point rfca.The combined approach was not superior to cryo alone.The literature publication reported the following patient complication: there was one patient who experienced a femoral pseudo-aneurysm which was treated with thrombin infection.No further patient complications have been reported as a result of this event.

• Brand Name: FLEXCATH STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• 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: 5448866
• MDR Text Key: 38637576
• Report Number: 3002648230-2016-00053
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K081049
• 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
• Report Date: 02/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/19/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 4FC12
• Device Catalogue Number: 4FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/08/2016
• 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: 00056 YR