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

Lot Number 0028457156

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

Patient Problems Chest Pain (1776); High Blood Pressure/ Hypertension (1908); Obstruction/Occlusion (2422); Vascular Dissection (3160)

Event Date 05/06/2022

Event Type  Injury  

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

It was reported that during an ablation procedure using an intellanav stablepoint open-irrigated catheter the patient required surgery for a heart blockage.During the procedure the physician was attempted to advance the catheter into the left ventricle through the aorta.It was difficult to pass the aortic valve and the catheter moved into the left main artery.About ten minutes later the patient mentioned they felt chest pain.Blood pressure was taken and found to be high at 140/90.An ecg was performed and a depression was observed in v3 and v6.An echocardiogram then ruled out tamponade.Next an angiogram was made of the coronary vessels and it was found that the proximal portion of the left main artery [lm] was dissected and the left anterior descending artery [lad] was blocked.They patient was moved to an operating room for a coronary artery bypass grafting procedure.The grafting procedure was successful and the patient is recovering in the icu under sedation, currently there has not been a neurological assessment.The catheter is expected to be returned for analysis.Gfe: patient survived the operation and is in the icu under sedation, they have nod had a neurological assessment yet.The damage to the left main artery was a dissection.

Manufacturer Narrative

Correction to field b5 complaint summary.Correction to field d4: serial number.Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected, and no abnormalities were found.They then tested the functionality of the catheter's steering and maneuvering capabilities which all were within acceptable specifications.Next, they electrically tested the catheter, no electrical issues or shorts were identified.Overall, testing did not find any defects or evidence that the device malfunctioned in a way that could have caused or contributed to the event.

Event Description

It was reported that during an ablation procedure using an intellanav stablepoint open-irrigated catheter the patient required surgery for a heart blockage.During the procedure the physician was attempted to advance the catheter into the left ventricle through the aorta.It was difficult to pass the aortic valve and the catheter moved into the left main artery.About ten minutes later the patient mentioned they felt chest pain.Blood pressure was taken and found to be high at 140/90.An ecg was performed and a depression was observed in v3 and v6.An echocardiogram then ruled out tamponade.Next an angiogram was made of the coronary vessels and it was found that the proximal portion of the left main artery [lm] was dissected and the left anterior descending artery [lad] was blocked.They patient was moved to an operating room for a coronary artery bypass grafting procedure.The grafting procedure was successful and the patient is recovering in the icu under sedation, currently there has not been a neurological assessment.The catheter has been returned 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: 14402822
• MDR Text Key: 291705631
• Report Number: 2134265-2022-05537
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 07/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2023
• Device Lot Number: 0028457156
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/26/2021
• 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
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention