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

Model Number M004ERFSDS96200

Device Problem Fluid/Blood Leak (1250)

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

Event Date 01/05/2022

Event Type  malfunction  

Event Description

It was reported that during a paroxysmal atrial fibrillation procedure with a intellanav stablepoint open-irrigated catheter, flushing of the tubing was performed prior to insertion of the catheter inside the patient.Air bubbles remained even after continued flushing, the connection of the flush port of the ablation catheter was checked, and the procedure was interrupted because the connection was bent and air was mixed in.As a result, this catheter was replaced and the procedure was successfully completed without any patient complications.The catheter has been returned to boston scientific for analysis.

Manufacturer Narrative

Visual inspection of this catheter revealed that the tubing set was partially detached from the luer.Device history record review confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.

Event Description

It was reported that during a paroxysmal atrial fibrillation procedure with a intellanav stablepoint open-irrigated catheter, flushing of the tubing was performed prior to insertion of the catheter inside the patient.Air bubbles remained even after continued flushing, the connection of the flush port of the ablation catheter was checked, and the procedure was interrupted because the connection was bent and air was mixed in.As a result, this catheter was replaced and the procedure was successfully completed without any patient complications.The catheter has been returned to boston scientific for analysis.

• 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 13360017
• MDR Text Key: 284526343
• Report Number: 2134265-2022-00723
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/18/2023
• Device Model Number: M004ERFSDS96200
• Device Lot Number: 0027521258
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/26/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/05/2022
• Initial Date FDA Received: 01/26/2022
• Supplement Dates Manufacturer Received: 02/02/2022
• Supplement Dates FDA Received: 03/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/18/2021
• 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