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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Cardiac Tamponade (2226)

Event Date 01/01/2015

Event Type  Injury  

Event Description

Martirosyan m, kiss a, nagy-balo e, et al.Learning curve in circular multipolar phased radiofrequency ablation of atrial fibrillation.Cardiology journal.2015;22(3):260-266.Background: although atrial fibrillation (af) ablation is considered a technically challenging procedure, studies on the learning curve of different pulmonary vein isolation (pvi) techniques are limited.We investigated the time-dependent changes in procedural parameters, complication rates, and in the 1-year clinical outcome during our initial experience with circular multipolar phased radiofrequency (rf) ablation.Methods and results: the first 132 consecutive patients (40 female; age: 56.6 ± 10.4 years) who underwent pvi with phased rf ablation for paroxysmal or persistent af at our center were included in the study.Procedural parameters and atrial arrhythmia free survival were compared in the first, second and third group of 44 successive patients.All pulmonary veins were successfully isolated in 44 (100%), 41 (93.8%) and 42 (95.5%) patients in tierce 1, 2 and 3, respectively (p = 0.233).The number of rfapplications (per vein) required for isolation and fluoroscopy times demonstrated a significant decrease with experience, and a trend towards lower procedure times in tierces 2 and 3 was also observed.Atrial arrhythmia-free survival rates at 12 months postablation were 68.18%, 75%, and 70.75% in tierce 1, tierce 2 and tierce 3, respectively (p = 0.772).Pericardial tamponade requiring percutaneous subxiphoid drainage occurred in 1 patient (tierce 3) as the only significantprocedural complication.Conclusions: a learning curve effect was demonstrated in fluoroscopy times and in the number of rf applications but not in the acute success and in the long-term arrhythmia-free survival with circular multipolar rf ablations.The literature publication reports the following complications:one patient experienced pericardial tamponade, which required drainage.No further patient complications were reported as a result of this event.

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.Referenced article: martirosyan m, kiss a, nagy-balo e, et al.Learning curve in circular multipolar phased radiofrequency ablation of atrial fibrillation.Cardiology journal.2015;22(3):260-266.(b)(4).

• Brand Name: FLEXCATH STEERABLE SHEATH
• Type of Device: CATHETER, STEERABLE
• Manufacturer (Section D): MEDTRONIC CRYOCATH LP; 16771 chemin ste-marie; kirkland,qc H9H 5H3; 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: 4952331
• MDR Text Key: 6191551
• Report Number: 3002648230-2015-00204
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K081049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 07/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2015
• 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
• Date Manufacturer Received: 07/07/2015
• 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