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 Stroke/CVA (1770)

Event Date 03/09/2023

Event Type  Injury  

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.

Event Description

It was reported that post an ablation procedure to treat atrial fibrillation (afib) in the left atrium (la), an intellanav stablepoint catheter was selected for use.The mapping system used was rhythmia, software version 4.5.Echo imaging was performed to rule out thrombus pre-procedure.No computed tomography (ct) was performed prior the procedure.Shortly after the patient was discharged from the hospital, the patient returned with a stroke.It was unknown whether the event was caused by the intellanav stablepoint catheter.No fibrin or coagulant were seen on the tip of the catheter.The nature of the stroke was thrombotic.No air was seen inside of the patient on imaging.A thrombectomy was performed successfully, and the anticoagulation status before, during and after the procedure was 400 seconds.Between the initial act and last act recorded there were about 2 hours of difference.There were little neurological symptoms.The patient was not taking any medications.

Event Description

It was reported that post an ablation procedure to treat atrial fibrillation (afib) in the left atrium (la), an intellanav stablepoint catheter was selected for use.The mapping system used was rhythmia, software version 4.5.Echo imaging was performed to rule out thrombus pre-procedure.No computed tomography (ct) was performed prior the procedure.Shortly after the patient was discharged from the hospital, the patient returned with a stroke.It was unknown whether the event was caused by the intellanav stablepoint catheter.No fibrin or coagulant were seen on the tip of the catheter.The nature of the stroke was thrombotic.No air was seen inside of the patient on imaging.A thrombectomy was performed successfully, and the anticoagulation status before, during and after the procedure was 400 seconds.Between the initial act and last act recorded there were about 2 hours of difference.There were little neurological symptoms.The patient was not taking any medications.

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.Correction to the initial mdr in blocks b2 outcomes attrib to adv event, g1 manufacturing site, and h6 impact codes.

• 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: 16896122
• MDR Text Key: 314843900
• Report Number: 2124215-2023-20490
• 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: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/02/2023

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: 04/10/2023
• Initial Date FDA Received: 05/09/2023
• Supplement Dates Manufacturer Received: 05/11/2023
• Supplement Dates FDA Received: 06/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention; Other
• Patient Age: 80 YR
• Patient Sex: Female