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); Diminished Pulse Pressure (2606)

Event Date 12/21/2021

Event Type  Injury  

Event Description

During pulmonary vein isolation procedure an intellavnav mifi open-irrigated catheter were selected for use.A full map of the left atrium was created and the left pulmonary veins (pvs) were successfully isolated.Prior to moving to the right pvs, a drop in the aoritic oxygen pressure was observed.The physician used intracardiac echocardiography to visualize the pericardial space and no effusion we present.The patient then went into pulseless electrical activity (pea) and cardiopulmonary resuscitation was started.Equipment was removed and the patient was extubated.The patient was moved to coronary care unit in critical condition.The physician does not attribute the event to any specific product.No additional information was provided.

Manufacturer Narrative

The intellanav mifi open- irrigated catheter was returned to boston scientific for analysis.During the product analysis unit passes visual, functional, dimensional, continuity and electrical tests and showed no evidence or defects that could have contributed to the event.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

During pulmonary vein isolation procedure an intellavnav mifi open-irrigated catheter were selected for use.A full map of the left atrium was created and the left pulmonary veins (pvs) were successfully isolated.Prior to moving to the right pvs, a drop in the aoritic oxygen pressure was observed.The physician used intracardiac echocardiography to visualize the pericardial space and no effusion we present.The patient then went into pulseless electrical activity (pea) and cardiopulmonary resuscitation was started.Equipment was removed and the patient was extubated.The patient was moved to coronary care unit in critical condition.The physician does not attribute the event to any specific product.No additional information was provided.

• 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: 13308503
• MDR Text Key: 284137798
• Report Number: 2134265-2022-00481
• 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: 03/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/17/2023
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0028043658
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization