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

Model Number M004PMR96200

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

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

Event Date 01/14/2019

Event Type  Injury  

Event Description

It was reported that a pericardial effusion was experienced.After cryoablation, 3d mapping and radiofrequency (rf) ablation with an intellanav mifi open-irrigated catheter and an intellamap orion mapping catheter, a pericardial effusion was observed after post rf ablation mapping.The anesthesiologist noticed the patient's blood pressure was low and an effusion was confirmed.The physician asked for a pericardiocentesis kit and was able to drain the fluid.The patient stabilized and was transported to a room for further observation.

• Brand Name: INTELLANAV MIFI OPEN-IRRIGATED
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 8273979
• MDR Text Key: 133973778
• Report Number: 2134265-2019-00327
• 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: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/29/2020
• Device Model Number: M004PMR96200
• Device Catalogue Number: 87047
• Device Lot Number: 0022864307
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/14/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/30/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: INTELLAMAP ORION CATHETER
• Patient Outcome(s): Required Intervention