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

Model Number 4FC12

Device Problem Insufficient Information (3190)

Patient Problem Inflammation (1932)

Event Date 01/01/2015

Event Type  Injury  

Manufacturer Narrative

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 male/58 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: complications in the setting of percutaneous atrial fibrillation ablation using radiofrequency and cryoballoon techniques: a single-center study in a large cohort of patients.International journal of cardiology.2015;196:42-49.(b)(4).

Event Description

A journal article was received which contained information regarding 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: hematoma, pseudoaneurysm, cardiac tamponade, pericarditis, arteriovenous fistula, phrenic nerve palsy (pnp), stroke, transient st elevation.Medical/surgical intervention was taken.No further patient complications have been reported as a result of this event.Mugnai g, irfan g, de asmundis c, et al.Complications in the setting of percutaneous atrial fibrillation ablation using radiofrequency and cryoballoon techniques: a single-center study in a large cohort of patients.International journal of cardiology.2015;196:42-49.Background the aim of this study was to assess the overall incidence of complications in a large sample of consecutive patients having undergone pulmonary vein (pv) isolation, evaluating also the rate of complications in radiofrequency (rf) and cryoballoon (cb) ablation technologies.Methods and results from january 2008 to december 2014, 1352 consecutive pv isolation procedures were performed in our center; a total amount of 1233 af ablation procedures fulfilling inclusion criteria was finally taken into consideration for our analysis.A total of 642 procedures were performed using rf ablation technology and 591 using cb system.Serious adverse events occurred in 36 procedures (2.9%): specifically, vascular complications in 14 (1.1%); cardiac tamponade in 13 (1.0%); a thromboembolic event in 4 (0.3%); and atrial-esophageal fistula, pv intramural hematoma, retroperitoneal hematoma, pleural hematoma and persisting phrenic nerve palsy all occurred in 1 patient individually (0.1%).No deaths related to the procedure occurred.The complication rate did not significantly differ in the rf and cb groups (respectively, 3.6% vs 2.2%; p = 0.1).Complication rates considerably decreased over the study period from 4.67% in 2008 to 1.55% in 2014.Interestingly, each 1-point increase in the cha<(><<)>inf>2<(><<)>/inf>ds<(><<)>inf>2 <(><<)>/inf>-vasc score was found to increase by 51% the likelihood of a serious adverse event.Conclusions the incidence of serious adverse events following af ablation procedures was 2.9%.Vascular complications were the most frequent complication followed by tamponade and thromboembolic events.The rate of complications considerably decreased over time.Cha<(><<)>inf>2<(><<)>/inf>ds<(> <<)>inf>2<(><<)>/inf>-vasc score was found to be associated with higher risk of complications.

• Brand Name: FLEXCATH ADVANCE 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: 5057177
• MDR Text Key: 25044372
• Report Number: 3002648230-2015-00288
• 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
• Type of Report: Initial
• Report Date: 08/06/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/04/2015
• 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: 00058 YR