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

Model Number	87088
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	05/12/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during an procedure using an woven diagnostic electrode catheter the patient experienced pericardial effusion.The physician suspected the cause was the diagnostic catheter puncturing the right ventricular apex.The damage most likely occurred prior to the ablation part of the procedure.No interventions were performed for the pericardial effusion or the puncture.The procedure had been completed by the time of discovery and the patient is expected to make a full recovery.The catheter is not expected to be returned as it was disposed of by the site.
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.
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
It was reported that during an procedure using an woven diagnostic electrode catheter the patient experienced pericardial effusion.The physician suspected the cause was the diagnostic catheter puncturing the right ventricular apex.The damage most likely occurred prior to the ablation part of the procedure.No interventions were performed for the pericardial effusion or the puncture.The procedure had been completed by the time of discovery and the patient is expected to make a full recovery.The catheter is not expected to be returned as it was disposed of by the site.

• 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
• Manufacturer (Section G): C R BARD INC; po box 75767; 75767; charlotte NC 28275
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 14594700
• Report Number: 2134265-2022-06382
• Device Sequence Number: 11287060
• Product Code: DRF
• UDI-Device Identifier: 08714729898825
• UDI-Public: 08714729898825
• Combination Product (Y/N): N
• Initial Reporter State: TN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2022

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: 02/28/2026
• Device Model Number: 87088
• Device Catalogue Number: 87088
• Device Lot Number: GFFN1994
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/12/2022
• Supplement Date Received by Manufacturer: 06/06/2022
• Initial Report FDA Received Date: 06/03/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/03/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female