MAUDE Adverse Event Report: ST. JUDE MEDICAL ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

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

Patient Problems Inflammation (1932); Cardiac Perforation (2513); Pseudoaneurysm (2605)

Event Type  Injury  

Manufacturer Narrative

Concomitant devices: flexability se catheter, event date unknown.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 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 number: 3005334138-2020-00429.The following was published in circulation arrhythmia and electrophysiology in an article titled ¿complete electroanatomic imaging of the diastolic pathway is associated with improved freedom from ventricular tachycardia recurrence¿ by hadjis a, frontera a, rosario limite l, et al., 28 july 2020.¿the development of multielectrode mapping catheters has expanded the spectrum of mappable ventricular tachycardias (vts).Full diastolic pathway recording has been associated with a high rate of vt termination during radiofrequency (rf) ablation as well as non-inducibility at study end.However, the role of diastolic pathway mapping on vt recurrence has yet to be clearly elucidated.We aimed to explore the role of complete diastolic pathway activation mapping on vt recurrence.A retrospective analysis was performed in 85 patients referred to our institution for vt ablation from december 2017 to june 2019.Periprocedural complications included 3 cases of pericarditis, 2 femoral pseudoaneurysms, and 2 cases of cardiac tamponade treated successfully with pericardial drain.¿ doi: 10.1161/circep.120.008651.

• Brand Name: ADVISOR HD GRID MAPPING CATHETER, SENSOR ENABLED
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 10543489
• MDR Text Key: 207232037
• Report Number: 3005334138-2020-00428
• Device Sequence Number: 1
• Product Code: DRF
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K172393
• 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: 09/16/2020

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 09/14/2020
• Initial Date FDA Received: 09/16/2020
• 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): Required Intervention