MAUDE Adverse Event Report: ST. JUDE MEDICAL FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

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

Patient Problems Nerve Damage (1979); Cardiac Perforation (2513)

Event Type  Injury  

Event Description

Manufacturing ref: 3005334138-2023-00282.The following was published in the elsevier inc.Publication date: 5/1/2023 in an article titled "pulmonary vein isolation with and without posterior wall isolation in paroxysmal atrial fibrillation: improve-paf trial", aryana arashr md, phd.This retrospective study examined the outcomes of cryoballoon pvi vs cryoballoon pvi and pwi in patients with symptomatic paf during long-term follow-up.Using the nearest-neighbor method, a 1:1 matched sample of patients receiving pvi alone and pvi and pwi was created.An abbott tacticath se and flexibility se ablation catheter were used to complete the ablations.4 patients experienced transient phrenic nerve palsy, 1 patient experienced persistent phrenic nerve palsy, and 3 patients experienced pericardial effusions.

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 incidents could not be conclusively determined.Per the ifu, cardiac perforation is a known risk during the use of this device.

• Brand Name: FLEXABILITY¿ ABLATION CATHETER, SENSOR ENABLED¿ CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: janna parks ; 5050 nathan lane north; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17206122
• MDR Text Key: 317987184
• Report Number: 3005334138-2023-00283
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P110016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 07/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2023
• 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: 07/06/2023
• 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: TACTICATH CONTACT FORCE ABLATION CATHETER SE
• Patient Outcome(s): Other