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

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

Patient Problem Heart Block (4444)

Event Date 02/21/2023

Event Type  Injury  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.

Event Description

It was reported that a intellanav stablepoint open-irrigated was selected for a redo pulmonary vein isolation (pvi) and avo-tricuspid isthmus (cti) procedure.First, the pvs were re-isolated.Then the physician went on the cti line alone with ablation catheter as the split was only 70ms.The physician decided not to map right atrium and do additional ablations with fluoro and just 3d tags on the line.While ablating the cti line there came 2 to 1 conduction from atrium to ventricle.The ablation was stopped, and the conduction came back quickly one to one (a-v).Physician thought it was some vagal response/reflective response, and decided to give atropine.Cti ablations continued.There came cti line block, but some additional lesions were given and in the last ablation observed again 2 to 1 conduction from atrium to ventricle.Ablations were stopped and in less than a minute the conduction came back one to one (a to v).During the waiting period cti line split reduced from about +100ms back to 70ms.The physician decided not to make any further ablations.A couple of hours after the case the patient monitor some conduction problems from atrium to ventricle.In the film there was p-waves missing the qrs.Patient is scheduled to have a pacemaker implanted.

• 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 DE COSTA RICA S.R.L.; 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: 16495493
• MDR Text Key: 310793104
• Report Number: 2124215-2023-09505
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: FI
• 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
• Report Date: 03/07/2023

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
• Initial Date Manufacturer Received: 02/21/2023
• Initial Date FDA Received: 03/07/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention