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

Model Number 87092

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914); Pericardial Effusion (3271)

Event Date 03/10/2021

Event Type  Injury  

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 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
• Type of Device: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): C R BARD INC; 75767; charlotte NC 28275
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 11674858
• MDR Text Key: 245756121
• Report Number: 2134265-2021-04904
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 08714729901600
• UDI-Public: 08714729901600
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Model Number: 87092
• Device Catalogue Number: 87092
• Device Lot Number: GFEW1587
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/15/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/09/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention