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

Model Number	87089
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271)
Date of Event	07/23/2021
Type of Reportable Event	Serious Injury
Additional 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 or Problem Description
During an pacing and mapping procedure for premature ventricular contractions a intellanav mifi open-irrigation catheter and a woven diagnostic catheter were selected for use.It was reported that epicardial effusion and cardiac tamponade were observed via intracardiac echocardiography.Tamponade was further confirmed by ultrasound imaging.It was unclear which device caused the observed event.The physician commented that an intellamap orion catheter also used in the procedure did not contribute to the effusion or tamponade.No resistance were felt while maneuvering the catheters.Pericardiocentesis was performed and the patient has recovered and been discharged from the hospital.

• Brand Name: WOVEN
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12348861
• Report Number: 2134265-2021-10652
• Device Sequence Number: 17465867
• Product Code: DRF
• UDI-Device Identifier: 08714729899693
• UDI-Public: 08714729899693
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/20/2021

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: 01/28/2026
• Device Model Number: 87089
• Device Catalogue Number: 87089
• Device Lot Number: GFFN1942
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/20/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: INTELLAMAP ORION CATHETER; INTELLANAV MIFI OPEN-IRRIGATED (LOT 0027164885)
• Outcome Attributed to Adverse Event: Required Intervention