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); Pericardial Effusion (3271)

Event Date 09/06/2019

Event Type  Injury  

Manufacturer Narrative

It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that the patient experienced a pericardial effusion.An intellanav mifi open-irrigated catheter and an intellamap orion catheter were selected for use for a myocardial ablation procedure to treat atrial fibrillation (af).The orion was advanced from the right superior pulmonary vein (rspv) to right inferior pulmonary vein (ripv) and the intellanav mifi open-irrigated was used around the right pulmonary vein (rpv).After septal puncture, enlarged isolation on the right pulmonary vein was performed.However, there was energization that local impedance decreased sharply at direct sense.Immediately after that, blood pressure decreased upon measurement.An echocardiogram showed accumulation of pericardial fluid, so drainage was performed.About 200cc of pericardial fluid was removed, but hemostasis was able to perform in a relatively short time.The physician believed the intellanav mifi open-irrigated catheter caused the pericardial effusion.It was unclear in what energization cardiac tamponade occurred.The physician thinks that it is possible that cardiac tamponade occurred during last energization.No patient information was available.No visual damage or functional issues were noted on this device.No resistance was felt when 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: 9125371
• MDR Text Key: 161244740
• Report Number: 2134265-2019-11704
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P150005/S017
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/26/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention