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

Model Number M004IDERFS96200

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

Patient Problem Atrial Flutter (1730)

Event Date 02/01/2022

Event Type  Injury  

Event Description

(b)(6) clinical study (b)(6).It was reported that following an index ablation procedure on (b)(6) 2021 involving an intellanav stablepoint open-irrigated catheter, the patient presented to the emergency room with a heart rate between 160 and 170 beats per minute.An electrocardiogram (ecg) was conducted diagnosed with rapid atrial flutter.The patient then received adenosine and intravenous diltiazem.They were admitted to the hospital and overnight their sinus rhythm became normal, so they were discharged the next day.The catheter is not expected to be returned as the complication occurred after the procedure was completed.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Corrections to field d4: model number.Corrections to field: d4: serial number.

Event Description

Newton af clinical study (b)(6).It was reported that following an index ablation procedure on 02 december 2021 involving an intellanav stablepoint open-irrigated catheter, the patient presented to the emergency room with a heart rate between 160 and 170 beats per minute.An electrocardiogram (ecg) was conducted diagnosed with rapid atrial flutter.The patient then received adenosine and intravenous diltiazem.They were admitted to the hospital and overnight their sinus rhythm became normal, so they were discharged the next day.The catheter is not expected to be returned as the complication occurred after the procedure was 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: 13672507
• MDR Text Key: 286637833
• Report Number: 2134265-2022-02486
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/12/2023
• Device Model Number: M004IDERFS96200
• Device Lot Number: 0026800698
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/12/2021
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 67 KG