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

Model Number	87092
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)
Date of Event	03/10/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported that a intellanav mifi open-irrigated ablation catheter and an intellamap orion high resolution mapping catheter were used in a atrial fibrillation ablation procedure.When hemostasis was performed slightly low blood pressure was noted and pericardial fluid was slightly accumulated.This was confirmed with echocardiography.A pericardial drain was performed.It was noted that bradycardia continued after the atrial fibrillation was stopped.The patient then had a non-boston scientific pacemaker implanted.No additional patient complications were reported.The device was discarded and will not be returned for analysis.It was further reported that a woven diagnostic electrode catheter was also used the atrial fibrillation ablation procedure.

• 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: 11674858
• Report Number: 2134265-2021-04904
• Device Sequence Number: 3124728
• Product Code: DRF
• UDI-Device Identifier: 08714729901600
• UDI-Public: 08714729901600
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/15/2021

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: 09/28/2025
• Device Model Number: 87092
• Device Catalogue Number: 87092
• Device Lot Number: GFEW1587
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/19/2021
• Initial Report FDA Received Date: 04/15/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention