MAUDE Adverse Event Report: Biosense Webster Inc VIZIGO; Introducer, Catheter

Catalog Number	D138501
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a vizigo and catheter for which biosense webster¿s product analysis lab (pal) identified the hemostatic valve dislodged inside the hub of the device.It was initially reported by the customer that the dilatator could not go through the valve of the vizigo sheath.Issue happened before the operation.The sheath was not used on the patient, therefore, no patient hazard/consequence and the procedure could be finished normally.There was no damage to the sheath or dilator noticed and no occlusion was noticed when irrigating the sheath.No observable blockage.The customer's reported impeded sheath issue is not considered to be mdr reportable since the potential risk that it could cause or contribute to a serious injury or death to the operator or patient is remote.On 13-jul-2026, the bwi pal revealed that a visual inspection of the returned device found the hemostatic valve dislodged inside the hub of the device.This findings was reviewed and assessed as an mdr reportable malfunction since the integrity of the device has been compromised.
Additional Manufacturer Narrative
Device evaluation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.Following j&j medtech procedures, a visual inspection and functional testing was conducted on the returned device following internal procedures.Visual analysis revealed that the hemostatic valve was dislodged inside the hub of the device.Microscopic examination of the hemostatic valve surface showed stress marks on the star section.A device history record was performed for the finished device batch number, and no internal actions were identified.The hemostatic valve dislodged could be related to the impeded device issue reported by the customer, the complaint was confirmed.The potential cause of the separation and stress marks of the hemostatic valve could be related to the incorrect insertion of the dilator into the sheath and excessive force to manipulate the device; however, this could not be conclusively determined.The instructions for use (ifu) contain the following information: use best practices for inserting or retracting any device at the hemostatic valve.Monitor any potential air entrapped and completely aspirate any observed air out of the side port; slowly remove or insert the dilator or other devices.As part of johnson & johnson medtech¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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).

• 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50182985
• Report Number: 3013300026-2026-02540
• Device Sequence Number: 9860560
• Product Code: DYB
• UDI-Device Identifier: 10846835016253
• UDI-Public: (01)10846835016253(17)280305(10)00003155
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K170997
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: D138501
• Device Lot Number: 00003155
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/01/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 08/07/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/06/2026
• 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
• Patient Sex: Unknown