MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WOVEN; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Model Number	M0047FMC006750
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	01/07/2019
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a pericardial effusion was experienced.On (b)(6) 2019, during an ablation procedure for atrial flutter and atrial fibrillation, the physician mapped in the right atrium with an intellamap orion catheter and also ablated in several areas in the right atrium with an intellanav mifi open-irrigated catheter.It was a difficult transseptal with non-boston scientific devices.During transseptal, the physician noticed a drop in the patient's blood pressure, so the physician did an echocardiogram and observed an effusion.So, he put in a pericardiocentesis catheter post transseptal before mapping on the left side, drained fluid out of the pericardial space and then mapped and ablated in the left atrium.The effusion continued during mapping ablation in the left atrium.They ended up opening the patient's chest and closing the area that caused the effusion.The patient was doing well as of (b)(6) 2019.The physician wasn't sure if the effusion happened in transseptal.It was reported that the patient had a persistent left subclavian vein, an abnormal structural aspect of the patient.During the transseptal access, it was just the transseptal equipment and the woven diagnostic electrode catheters that were in the patient during that time.

• Brand Name: WOVEN
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8266629
• Report Number: 2134265-2019-00216
• Device Sequence Number: 11292777
• Product Code: DRF
• UDI-Device Identifier: 08714729902355
• UDI-Public: 08714729902355
• Combination Product (Y/N): N
• Initial Reporter State: UT
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/22/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/28/2023
• Device Model Number: M0047FMC006750
• Device Catalogue Number: 87092
• Device Lot Number: GFCR2232
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2019
• Initial Report FDA Received Date: 01/22/2019
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ABLATION CATH: BSC NAV MIFI OI; DIAGNOSTIC CATH: BSC WOVEN; INTELLAMAP ORION CATHETER
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR