MAUDE Adverse Event Report: ST. JUDE MEDICAL, INC. AGILIS¿ INTRODUCER, UNKNOWN; CATHETER, INTRODUCER

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Nerve Damage (1979); Cardiac Perforation (2513); Vascular Dissection (3160)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.The lot number was not provided so a review of the device history record was not possible.Based on the information received, the cause of the reported pericardial effusion, phrenic nerve injury, and dissection could not be conclusively determined.

Event Description

Related manufacturing ref: 9680001-2019-00072, 2030404-2019-00030, 2182269-2019-00053.The following was published in crossmark in an article titled, "hybrid atrial fibrillation ablation in patients with persistent atrial fibrillation or failed catheter ablation" by m.I.H.Al-jazairi, m.Rienstra, t.J.Klinkenberg, m.A.Mariani, i.C.Van gelder, and y.Blaauw on 04 february 2019.Fifty patients were included, 57± 9 years, 38 (76%) men, 5 (10%) paroxysmal, 34 (68%) persistent and 11 (22%) long-standing persistent af.At 1-year 38 (76%) maintained sinus rhythm off antiarrhythmi drugs.Majority of recurrences were atrial flutter (9/12 patients).Success was associated with type of af (p= 0.039).Patients with paroxysmal af had highest success, patients with longstanding persistent af had lowest success.Seven (14%) patients had procedure-related complications.Quality of life improved after ablation in patients who maintained sinus rhythm (sr).Seven (14%) patients suffered complications during and after the procedure.Two (4%) had bleeding during the epicardial procedure necessitating thoracotomy; one due to an injury to the pulmonary artery and the other due to injury to the right inferior pulmonary vein.Both patients recovered completely without any sequelae.Two (4%) had permanent phrenic nerve injury, 1 (2%) developed pericardial and pleural effusion requiring drainage, 1 (2%) pleural effusion requiring drainage, and 1 (2%) was known with a latent sick sinus syndrome before the procedure, requiring a ddd-pacemaker after restoration of sr.Total hospital stay was 6± 2 days (tab.4).

• Brand Name: AGILIS¿ INTRODUCER, UNKNOWN
• Type of Device: CATHETER, INTRODUCER
• Manufacturer (Section D): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer (Section G): ST. JUDE MEDICAL, INC.; 14901 deveau place; minnetonka MN 55345
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 8562549
• MDR Text Key: 143478584
• Report Number: 2182269-2019-00052
• Device Sequence Number: 1
• Product Code: DYB
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K061363
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 04/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: INQUIRY¿ OPTIMA¿ DIAGNOSTIC CATHETER; SUPREME¿ ELECTROPHYSIOLOGY CATHETER; TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Patient Outcome(s): Other; Required Intervention