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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Pseudoaneurysm (2605)

Event Date 07/01/2015

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 baseline gender/age is female/(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: incidence and characteristics of complications in the setting of second-generation cryoballoon ablation: a large single-center study of 500 consecutive patients.Heart rhythm.2015;12(7):1476-1482.(b)(4).

Event Description

A journal article was received which contained information regarding cardiac ablation sheaths and catheters.Multiple patients were noted in the article; however, a one to one correlation could not be made with unique device serial numbers.The literature publication reports the following complications: hematomas, transient ischemic attack (tia), phrenic nerve palsy (pnp), cardiac tamponade, and pseudoaneurysm.No further patient complications were reported as a result of this event.Mugnai gmd, de asmundis c, ciconte g, et al.Incidence and characteristics of complications in the setting of second-generation cryoballoon ablation: a large single-center study of 500 consecutive patients.Heart rhythm.2015;12(7):1476-1482.Background the second-generation cryoballoon advance (cb-a) recently launched on the market has technical modifications designed to significantly improve procedural outcome with respect to the first-generation device.Objective the purpose of this study was to evaluate the overall incidence of complications in a large sample of patients having undergone pulmonary vein (pv) isolation with cb-a technology.Methods all consecutive patients who underwent pv isolation procedures using cb-a technology between june 2012 and february 2015 were considered.Exclusion criteria were presence of an intracavitary thrombus, uncontrolled heart failure, moderate or severe valvular disease, left atrial diameter ?55 mm, and contraindications to general anesthesia.Results during the study period, 500 consecutive patients (67% male, age 57.6 +/- 12.9 years) were enrolled.Major complications occurred in 10 patients (2.0%): vascular complications at the puncture site in 6 (1.2%), and thromboembolic events, cardiac tamponade, persisting phrenic nerve palsy, and retroperitoneal hematoma all occurred in a single patient respectively (0.2%).Phrenic nerve palsy occurred in 36 patients (7.2%) and did not revert in only 1 patient at final follow-up of 20 months.No deaths related to the procedure occurred.No predictors of major complication were found.Conclusion the present findings highlight that pv isolation using cb-a technology can be safely performed with a low incidence of adverse events.The incidence of major complications after atrial fibrillation ablation procedures using cb-a technology was 2% in our study.The most frequent complication consisted of vascular complications at the puncture site.No deaths related to the procedure occurred.

• Brand Name: FLEXCATH ADVANCED 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: 5050298
• MDR Text Key: 24901838
• Report Number: 3002648230-2015-00261
• Device Sequence Number: 1
• Product Code: DRA
• Combination Product (y/n): N
• Reporter Country Code: BE
• PMA/PMN Number: K123591
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Reporter Occupation: Physician
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2015
• 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: 08/06/2015
• 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): Hospitalization; Required Intervention
• Patient Age: 00062 YR