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

Lot Number 0029293465

Device Problem Defective Device (2588)

Patient Problem Arrhythmia (1721)

Event Date 08/24/2022

Event Type  Injury  

Event Description

During an ablation procedure a intellanav stablepoint open-irrigated was selected for use.Ventricular tachycardia (vt) occurred during partial annulus ablation, and returned to sinus rhythm when the ablation was stopped.According to the physician, he has experienced this event in the past when radio frequency output was leaking to another device, therefore, this device was replaced with another lot device.After replacement, the ablation was performed without any problems and the procedure was successfully completed.

Manufacturer Narrative

The catheter was returned to boston scientific for analysis.Visual inspection does not reveal any visual defects.No abnormal resistance was felt when actuating the steering mechanism in the functional test.Both right and left curves reach the specified area of the template, the device passed the dimensional test.The continuity test was performed, and the device was found within specifications.No shorts or opens were detected.Leak test was performed, and the lumen pressure decay was measured three times.The unit passed the test without problems.The noise test values were found typical and within specifications.The device was connected to rhythmia mapping system and it was recognized without any issues.The report complaint could not be confirmed,.

Event Description

During an ablation procedure a intellanav stablepoint open-irrigated was selected for use.Ventricular tachycardia (vt) occurred during partial annulus ablation, and returned to sinus rhythm when the ablation was stopped.According to the physician, he has experienced this event in the past when radio frequency output was leaking to another device, therefore, this device was replaced with another lot device.After replacement, the ablation was performed without any problems and the procedure was successfully completed.

• 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: 15455454
• MDR Text Key: 300237022
• Report Number: 2124215-2022-36842
• 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: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/26/2024
• Device Lot Number: 0029293465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/10/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/27/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other