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

Model Number 87047

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

Patient Problems Low Blood Pressure/ Hypotension (1914); Cardiac Tamponade (2226); Pericardial Effusion (3271)

Event Date 08/10/2023

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 a redo pulmonary vein isolation procedure, an intellanav mifi open-irrigated catheter was selected for use.After ablating the roof, fluid around the pericardium was noticed.Most likely related to the ablation catheter as was the only device in the left atrium.No resistance felt while maneuvering the catheter, but the physician did mention he did push a bit towards the roof in order to get better contact and he felt that was where the perforation happened.It was the second map, performed a good amount of lesions by the right superior pulmonary vein and performed lesions in the floor and roof line.It was about 2 hours into the procedure when pericardial effusion was observed.The pericardial effusion judged as a cardiac tamponade.Blood pressure was low as well.A perivac kit was used to perform a pericardiocentesis in order to get the fluid out of the heart, in which after the patient stabilized.Treatment was not able to be completed due to the effusion.Patient is expected to fully recover after the surgery.Catheter is expected to be returned for laboratory analysis.

Manufacturer Narrative

Intellanav mifi open-irrigated catheter was evaluated by boston scientific.Visual inspection noted the device has the catheter shaft bent/kinked at curve section.A functional test was done and the steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Finally, a dimensional test was performed and both right and left curves reach the specified area of the template, the device passed the dimensional test as per the document specification.The reported adverse events are known and documented in the labeling (including both short or long term known complications or adverse reactions).Laboratory analysis was able to find a kink in the shaft of the catheter.

Event Description

It was reported the patient experienced a pericardial effusion/cardiac tamponade.It was reported that during a redo pulmonary vein isolation procedure, an intellanav mifi open-irrigated catheter was selected for use.After ablating the roof, fluid around the pericardium was noticed.Most likely related to the ablation catheter as was the only device in the left atrium.No resistance felt while maneuvering the catheter, but the physician did mention he did push a bit towards the roof in order to get better contact and he felt that was where the perforation happened.It was the second map, performed a good amount of lesions by the right superior pulmonary vein and performed lesions in the floor and roof line.It was about 2 hours into the procedure when pericardial effusion was observed.The pericardial effusion judged as a cardiac tamponade.Blood pressure was low as well.A perivac kit was used to perform a pericardiocentesis in order to get the fluid out of the heart, in which after the patient stabilized.Treatment was not able to be completed due to the effusion.Patient is expected to fully recover after the surgery.Catheter is expected to be returned for laboratory analysis.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 17670736
• MDR Text Key: 322508552
• Report Number: 2124215-2023-46789
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729938361
• UDI-Public: 08714729938361
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0030706531
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention