MAUDE Adverse Event Report: BIOSENSE WEBSTER INC VIZIGO; INTRODUCER, CATHETER

Catalog Number	D138504
Medical Device Problem Codes	Mechanical Jam (2983); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Cardiac Tamponade (2226)
Date of Event	05/14/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being submitted pursuant to the provisions of 21 cfr, part 803.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a varipulse catheter and a vizigo sheath and the patient experienced cardiac tamponade that required pericardiocentesis.First it was reported that when the catheter was inserted into the patient¿s body, electrode #10 was displayed in black for the varipulse catheter with lot# 31817950l.The catheter was replaced with another new varipulse catheter with lot # 31814177l and the issue was resolved.Then it was reported that during ablation, pull wire disconnection occurred with the vizigo sheath with lot # 17411932.Additional ablation was discontinued and a post-map was created to confirm the gap, and the varipulse catheter (lot: 31814177l) was reinserted for additional ablation.However, this was performed because the vizigo sheath lot # 17411932 did not move as expected.The vizigo sheath lot # 17411932 was replaced with the another new one.Then, approximately 1¿2 minutes after manipulation of the varipulse catheter and vizigo short during preparation for vizigo short replacement, a decrease in blood pressure was noted and a cardiac tamponade occurred.Drainage was performed, and the procedure was completed after blood pressure recovered.Patient was transferred back to the intensive care unit).Patient fully recovered.The physician thinks that the cardiac tamponade was due to the manipulation of either the varipulse catheter or vizigo sheath when attempted to approach the devices to the pulmonary vein for a touch up ablation.It was reported that the vizigo sheath was not displayed on the carto 3 monitor and used under fluoroscopy for certain times.During the touch up attempt, the vizigo sheath was inside the left atrium (la) chamber and the varipulse catheter was advanced inside the vizigo sheath under fluoroscopy.The varipulse catheter tip came out of vizigo sheath, and the physician confirmed that the varipulse tip on the carto 3 monitor showed the tip was already at the posterior wall of the la.Then the catheters were not able to be moved.The physician thinks that either varipulse catheter or vizigo sheath damaged the posterior wall of la.The procedural act during the procedure was 400 seconds.There were 29 pfa ablations performed, all within the pulmonary veins.

• Brand Name: VIZIGO
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): FREUDENBERG MEDICAL LLC; 2301 centennial blvd; jeffersonville IN 47130
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 25488349
• Report Number: 3013300026-2026-01845
• Device Sequence Number: 10323038
• Product Code: DYB
• UDI-Device Identifier: 10846835026252
• UDI-Public: (01)10846835026252(17)280216(10)17411932
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup

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 Catalogue Number: D138504
• Device Lot Number: 17411932
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Supplement Date Received by Manufacturer: 06/15/2026; 06/17/2026
• Initial Report FDA Received Date: 06/12/2026
• Supplement Report FDA Received Date: 06/17/2026; 07/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/16/2026
• 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: Life Threatening; Required Intervention
• Patient Age: 76 YR
• Patient Sex: Male
• Patient Weight: 138 LB