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

Model Number 86493

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

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

Event Date 03/20/2020

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.During an ablation procedure with an intellatip mifi open-irrigated standard curve via a non-boston scientific 8.5f sheath on the anterior wall/roof of the left atrium (la), la mapping was performed with an intellamap orion catheter.A woven diagnostic electrode catheter was also being used at the time of event.Ablation was then performed with the intellanav mifi oi.Eventually, during ablation of the la anterior wall/roof, anesthesia told the electrophysiologist (ep) that the patient's blood pressure was low.The ep immediately halted radiofrequency (rf) delivery, performed a transthoracic echocardiogram (tee) and noted an acute (small/"trace") pericardial effusion.Anticoagulation therapy was immediately reversed and further imaging intervention was performed (tee) and the pericardium was accessed.Blood was removed from the pericardium and transfused back to the patient.The effusion would not resolve after over an hour of monitoring.The patient continued to deteriorate and cardiothoracic (ct) surgery was consulted.After further deterioration, the patient was sent for ct surgery.The physician did not attribute the event to any specific product.The catheters were disposed of and are not available for return.

• Brand Name: INTELLATIP 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: 9953653
• MDR Text Key: 187528304
• Report Number: 2134265-2020-04997
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P150005/S008
• 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: 04/13/2020

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: 86493
• Device Catalogue Number: 86493
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/20/2020
• Initial Date FDA Received: 04/13/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention