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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pericardial Effusion (3271)

Event Date 10/01/2015

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 characteristics of the patients referenced in the article is gender/age is male/(b)(6) 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: koektuerk bd, yorgun h, turan ch, et al.Cryoballoon ablation for pulmonary vein isolation in patients with persistent atrial fibrillation.Circ.Arrhythmia electrophysiol.2015;8(5):1073-1079.(b)(4).

Event Description

Koektuerk bd, yorgun h, turan ch, et al.Cryoballoon ablation for pulmonary vein isolation in patients with persistent atrial fibrillation.Circ.Arrhythmia electrophysiol.2015;8(5):1073-1079.Background - data regarding the freedom from atrial fibrillation (af) in the follow-up of persistent af patients is limited.The second-generation cryoballoon has better cooling properties compared with first-generation cryoballon.In this study, we aimed to assess the medium-term efficacy of second-generation cryoballoon in patients with persistent af.Methods and results - a total of 100 patients (63 +/- years, 80% male) with symptomatic persistent af, despite ?1 antiarrhythmic drug(s), who were scheduled for pulmonary vein isolation using second-generation cryoballoon were enrolled in this study.Follow-up was based on outpatient clinic visits, including holter ecgs.Recurrence was defined as a symptomatic or documented arrhythmia episode of >30 seconds excluding a 3-month blanking period.As a result, 393 pulmonary veins (7 patients with common ostium) were successfully isolated.Mean procedural and fluoroscopy times were 96.2 +/- 21.3 and 19.7 +/- 6.7 minutes, respectively.Phrenic nerve palsy occurred in 3% (3/100) of the patients.At a mean follow-up duration of 10.6 +/- 6.3 months, 67% of the patients were in sinus rhythm.Stepwise multivariable cox proportional hazard regression analysis showed that early af recurrence (hazard ratio 3.83, 95% confidence interval 1.91-7.68, the literature publication reports the following patient complications: three (3) patients who experienced "mild" pericardial effusion, which resolved spontaneously.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: 5255679
• MDR Text Key: 32451607
• Report Number: 3002648230-2015-00432
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 11/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2015
• 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: 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