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 Hematoma (1884); Tissue Damage (2104); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

The results of the investigation are inconclusive since the device was not returned for analysis.Review of the device history record was not possible as the lot number is unknown.Based on the information received, the cause of the reported incident remains unknown.

Event Description

Related manufacturing ref: 3005334138-2020-00285, 3008452825-2020-00342.The following was published in the j cardiovasc electrophysiol in an article titled ¿femoral vascular complications after catheter ablation in the current era: the utility of computed tomography imaging¿ ishikawa e, miyazaki s, mukai m, et al.The study was to investigate the incidence of femoral vascular complications in catheter ablation and factors associated with complications in the current era.This single-center observational study consisted of 311 consecutive patients who underwent catheter ablation at the university of fukui between april 2018 and march 2019.In total, five (1.6%) patients exhibited major complications at the femoral access site including two pseudoaneurysms, two avfs, and one active bleeding hematoma.The pseudoaneurysms and avfs were successfully eliminated by direct compression under ultrasound monitoring in all four patients.In the remaining one patient, extravasation from the branch of the medial femoral circumflex artery was successfully treated by a coil embolization by a radiologist.Concomitant devices: swartz¿ introducer, agilis¿ introducer.

• 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; 5050 nathan lane north; plymouth MN 55442
• Manufacturer Contact: stephanie o' sullivan ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 10276272
• MDR Text Key: 199158654
• Report Number: 3005334138-2020-00289
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/22/2020
• Initial Date FDA Received: 07/15/2020
• 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
• Patient Outcome(s): Other; Required Intervention