MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	M004R9620K20
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Perforation (2513); Pericardial Effusion (3271)
Date of Event	08/06/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
Same case as 2134265-2018-60443.It was reported a pericardial effusion and possible perforation occurred.An intellamap orion mapping catheter and an intellanav oi ablation catheter were selected for use during an atrial fibrillation and atrial flutter redo ablation procedure.After the left atrial map was completed, the orion was left in the left atrium.An intellanav oi was placed into the left atrium using a zurpaz sheath.At that time, the patient's blood pressure dropped considerably.Echocardiography was called; there was fluid in the pericardial space.The catheters and sheaths were removed from the left atrium due to pericardial effusion.A significant amount of blood was drained from the pericardial space and the patient was sent to the operating room due to bleeding and for possible surgery.It was determined the bleeding into the pericardial space fixed itself.The rest of the bleeding was due to the drain that was placed hitting the liver.The patient was expected to fully recover.There had not been any device issues during the procedure.The physician suspected a possible perforation while mapping in the left atrium with the orion; however, he wasn't sure.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; dc a330,; saint paul MN 55112
• MDR Report Key: 7842539
• Report Number: 2134265-2018-60442
• Device Sequence Number: 19167155
• Product Code: OAD
• UDI-Device Identifier: 08714729937449
• UDI-Public: 08714729937449
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/04/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 03/13/2021
• Device Model Number: M004R9620K20
• Device Catalogue Number: 87045
• Device Lot Number: 0021861312
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/06/2018
• Initial Report FDA Received Date: 09/04/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention