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

Lot Number 0030968576

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 07/10/2023

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).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 a procedure an intellanav stablepoint open-irrigated was selected for use.A puncture into the femoral vein was performed along with a double transeptal puncture.Afterwards mapping of the left atrium (la) occurred with the catheter without issues.After ablation of the right pulmonary veins transeptal access was lost and another puncture had to be done.About thirty minutes later, with more ablations performed during that time, a blood pressure decrease was noticed in the patient.An echocardiogram was performed, and a pericardial effusion was confirmed and treated immediately with pericardiocentesis.About 60 applications of radio frequency (rf) energy were performed before the observed complication.No popping or drastic impedance drop was noticed during ablation, nor was any high contact force or excessive movement of the catheter or patient noticed.The cause of the pericardial effusion was unknown.The procedure was able to be completed.The patient was admitted to intensive care as a result of the effusion but was expected to fully recover.

Manufacturer Narrative

Initial reporter phone: (b)(6).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 during a procedure an intellanav stablepoint open-irrigated was selected for use.A puncture into the femoral vein was performed along with a double transeptal puncture.Afterwards mapping of the left atrium (la) occurred with the catheter without issues.After ablation of the right pulmonary veins transeptal access was lost and another puncture had to be done.About thirty minutes later, with more ablations performed during that time, a blood pressure decrease was noticed in the patient.An echocardiogram was performed, and a pericardial effusion was confirmed and treated immediately with pericardiocentesis.About 60 applications of radio frequency (rf) energy were performed before the observed complication.No popping or drastic impedance drop was noticed during ablation, nor was any high contact force or excessive movement of the catheter or patient noticed.The cause of the pericardial effusion was unknown.The procedure was able to be completed.The patient was admitted to intensive care as a result of the effusion but was expected to fully recover.It was further reported that the catheter was at the left inferior pulmonary vein (lipv) when the pericardial effusion was noticed.A competitor company 8fr sheath was used with the catheter.The device is expected to be returned for analysis.

Event Description

It was reported that during a procedure an intellanav stablepoint open-irrigated was selected for use.A puncture into the femoral vein was performed along with a double transeptal puncture.Afterwards mapping of the left atrium (la) occurred with the catheter without issues.After ablation of the right pulmonary veins transeptal access was lost and another puncture had to be done.About thirty minutes later, with more ablations performed during that time, a blood pressure decrease was noticed in the patient.An echocardiogram was performed, and a pericardial effusion was confirmed and treated immediately with pericardiocentesis.About 60 applications of radio frequency (rf) energy were performed before the observed complication.No popping or drastic impedance drop was noticed during ablation, nor was any high contact force or excessive movement of the catheter or patient noticed.The cause of the pericardial effusion was unknown.The procedure was able to be completed.The patient was admitted to intensive care as a result of the effusion but was expected to fully recover.It was further reported that the catheter was at the left inferior pulmonary vein (lipv) when the pericardial effusion was noticed.A non-bsc company 8fr sheath was used with the catheter.It was indicated that the facility shipped the device to boston scientific for analysis, however the device was lost in transit.

Manufacturer Narrative

Additional device information updated.Initial reporter phone: (b)(6).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be 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: 17344406
• MDR Text Key: 319232225
• Report Number: 2124215-2023-37006
• Device Sequence Number: 1
• Product Code: OAE
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup
• Report Date: 05/31/2024

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
• Device Lot Number: 0030968576
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/10/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 07/18/2023; Not provided
• Supplement Dates FDA Received: 08/15/2023; 05/31/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention