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)

Event Date 05/17/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

Event Description

It was reported that the patient experienced a cardiac tamponade.Before an atrial fibrillation (af) ablation procedure, a transesophageal echo (tee) was performed and an existing, mild pericardial effusion was observed.After mapping the left atrium and completing the first set of lesions with an intellanav mifi open-irrigated ablation catheter, the anesthesiologist noticed a drop in the patient's blood pressure while we were completing a post ablation map.It was then confirmed with intracardiac echocardiography (ice) that the effusion had expanded and the patient had a tamponade.The patient's activated clotting time (act) was around 320 at the time.A pericardiocentesis was performed by the physician and protamine was administered.The patient was stable when leaving the electrophysiology (ep) lab and did not require surgery.The physician was not exactly sure when the tamponade occurred, but believed it was caused while ablating on the ridge between the left atrial appendage (laa) and left superior pulmonary vein (lspv); they went outside of the shell they created with the mapping system.The ablation catheter and a coronary sinus (cs) catheter were in the body at the time of the event.A non-boston scientific 11.5f sheath was used.No resistance was felt while maneuvering the catheters.

• 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: 8686689
• MDR Text Key: 147586692
• Report Number: 2134265-2019-06720
• 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: 06/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 01/10/2021
• Device Model Number: 87047
• Device Catalogue Number: 87047
• Device Lot Number: 0023173624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/17/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/11/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention