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

Model Number 3FC12

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 01/01/2015

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.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.Patient information is limited due to confidentiality concerns.The baseline gender/age of the patients represented in the article is male/(b)(6) years of age.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: outcomes of cryoballoon ablation in high-and low-volume atrial fibrillation ablation centres: a russian pilot survey.Biomed research international.2015;2015(591603):2314-6133.(b)(4).

Event Description

Mikhaylov en, lebedev ds, pokushalov ea, et al.Outcomes of cryoballoon ablation in high-and low-volume atrial fibrillation ablation centres: a russian pilot survey.Biomed research international.2015;2015(591603):2314-6133.Purpose.The results of cryoballoon ablation (cba) procedure have been mainly derived from studies conducted in experienced atrial fibrillation (af) ablation centres.Here, we report on cba efficacy and complications resulting from real practice of this procedure at both high-and low-volume centres.Methods.Among 62 russian centres performing af ablation, 15 (24%) used cba technology for pulmonary vein isolation.The centres were asked to provide a detailed description of all cba procedures performed and complications, if encountered.Results.Thirteen sites completed interviews on all cbas in their centres (>95% of cbas in russia).Six sites were high-volume af ablation (>100 af cases/year) centres, and 7 were low-volume af ablation.There was no statistical difference in arrhythmia-free rates between high-and low-volume centres (64.6 versus 60.8% at 6 months).Major complications developed in 1.5% of patients and were equally distributed between high-and lowvolume centres.Minor procedure-related events were encountered in 8% of patients and were more prevalent in high-volume centres.Total event and vascular access site event rates were higher in women than in men.Conclusions.Cba has an acceptable efficacy profile in real practice.In less experienced af ablation centres, the major complication rate is equal to that in high-volume centres.The literature publication reports the following patient complications: five (5) patients had pseudo-aneurysms.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: 5343806
• MDR Text Key: 35058453
• Report Number: 3002648230-2016-00004
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: RS
• 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: 12/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Physician
• Device Model Number: 3FC12
• Device Catalogue Number: 3FC12
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/10/2015
• 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): Life Threatening; Required Intervention
• Patient Age: 00054 YR