MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV STABLEPOINT OPEN-IRRIGATED; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION

Model Number M004ERFSDS96200

Device Problems Defective Device (2588); Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/21/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

During a procedure a intellanav stablepoint was selected for use.When the device was energized for the first time, a temperature error occurred.When the extension tube was checked, the base of the tube was found to be completely torn.The device was replaced and the procedure was completed without any patient complications.

Event Description

During a procedure a intellanav stablepoint was selected for use.When the device was energized for the first time, a temperature error occurred.When the extension tube was checked, the base of the tube was found to be completely torn.The device was replaced and the procedure was completed without any patient complications.

Manufacturer Narrative

The device was received at boston scientific for analysis.Visual inspection revealed a torn luer which contributes to flow of saline to the tip.Preventing flow leads to excessive heat in the distal tip which would trigger a temperature error on the generator.Ablation could not be performed to replicate issue due to an open flushline.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV STABLEPOINT OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FIBRILLATION
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12336853
• MDR Text Key: 267080437
• Report Number: 2134265-2021-10561
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M004ERFSDS96200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Date Manufacturer Received: 09/15/2021
• Patient Sequence Number: 1