MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY ABLATION CATHETER-UNKNOWN; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

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

Patient Problems Paralysis (1997); Cardiac Perforation (2513); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Based on the information received, the cause of the reported cardiac perforation, pseudoaneurysm or paralysis could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

Event Description

Related manufacturer reference: 2030404-2020-00029, 9680001-2020-00023.The following was published in the international journal of cardiovascular imaging in an article titled ¿combined use of electro-anatomic mapping system and intracardiac echocardiography to achieve zero-fluoroscopy catheter ablation for treatment of paroxysmal atrial fibrillation: a single centre experience" by jan, matev¿ , et al., 11 november 2019."we included 144 consecutive patients (69% males, age 60 ± 10 years, bmi 29 ± 4,6) referred for ca of symptomatic paroxysmal af.All procedures were performed only with eam system and ice.No fluoroscopy was used.Once the transseptal access was obtained a 10 or 20-polar circular mapping catheter (afocus ii¿; abbott, abbott park, (b)(4)) and an irrigated tip ablation catheter (acticath¿, flexability¿; both abbott, abbott park, (b)(4)) were placed inside the la and the 3d eam system was initialized.One patient had cardiac tamponade immediately after double transseptal puncture, which resulted in termination of the procedure.A possible reason for tamponade could be accidental puncture of the contralateral la wall in a patient with only slightly enlarged la and a floppy interatrial septum.Two patients had a pseudoaneurysm of the right femoral artery that required surgical intervention.Four patients had a peri-procedural pericardial effusion, which resolved spontaneously without any treatment.All four pericardial effusions manifested shortly after the procedure, which implies they were not a consequence of transseptal puncture, but rather of transmural rf lesions.One patient had prolonged paresis of the right diaphragm, which eventually resolved after 6 months.".

• Brand Name: FLEXABILITY ABLATION CATHETER-UNKNOWN
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): ST. JUDE MEDICAL; 5050 nathan lane north; plymouth MN 55442
• Manufacturer (Section G): ST. JUDE MEDICAL (AFD-PLYMOUTH); 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10051516
• MDR Text Key: 190765692
• Report Number: 3005334138-2020-00169
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SI
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/13/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/13/2020
• Is this an Adverse Event Report?: Yes
• 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: 04/20/2020
• 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¿ AFOCUS¿ DIAGNOSTIC CATHETER; TACTICATH¿ QUARTZ CONTACT FORCE ABLATION CATHETER
• Patient Outcome(s): Other