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); Tachycardia (2095); Pericardial Effusion (3271)

Event Date 01/06/2023

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

During a redo atrial fibrillation (af) procedure a intellanav mifi open-irrigated was selected for use.During the procedure, a line was created from the left inferior pulmonary vein (lipv) to the mitral annulus.After the third ablation lesion, there was a moment where the tachycardia sped up, and cardiac pressure dropped.Under echocardiogram, a large pericardial effusion was observed.Pericardiocentesis kit was used, and the patient is expected to fully recover.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected, and no abnormalities were found.Functional test revealed the catheter's steering and maneuvering capabilities were within acceptable specifications.Electrical tests revealed 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

During a redo atrial fibrillation (af) procedure a intellanav mifi open-irrigated was selected for use.During the procedure, a line was created from the left inferior pulmonary vein (lipv) to the mitral annulus.After the third ablation lesion, there was a moment where the tachycardia sped up, and cardiac pressure dropped.Under echocardiogram, a large pericardial effusion was observed.Pericardiocentesis kit was used, and the patient is expected to fully recover.

• 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: 16292559
• MDR Text Key: 308732782
• Report Number: 2124215-2023-04020
• 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: Consumer,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2023
• 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: 0030152288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/17/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other