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

Catalog Number	D138505
Medical Device Problem Code	Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 19-jun-2025.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual analysis revealed a perforation on the tip of the vizigo sheath, the perforation could be the result of the handling of the device during the procedure, since the customer's report regarding ¿the vizigo could not be inserted in la.When the sheath was removed from the cardiac cavity, the tip of the sheath was found to be dented.¿ a device history review was performed for the finished device batch number, and no internal actions were identified.The tip issue reported by the customer was confirmed.The potential cause of the perforation on the tip could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The sheath instructions for use (ifu) contain the following recommendations: use fluoroscopy and/or intracardiac ultrasound to monitor the advancement of the catheter and removal of the catheter from the sheath.Move the catheter carefully to avoid cardiac damage, perforation, or tamponade.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Manufacturer¿s reference number: (b)(4).
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a vizigo.After brockenbrough (bb) with the vizigo sheath, the vizigo sheath could not be inserted in the left atrium (la).When the sheath was removed from the cardiac cavity, the tip of the sheath was found to be dented.Resolved by replacing the sheath with another new one.The procedure was completed without any patient consequence.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.The issue of the vizigo sheath could not be inserted in the la with the tip found to be dented was assessed as mdr reportable.The biosense webster, inc.Product analysis lab received the device for evaluation and per the evaluation completion on 21-jul-2025 revealed a perforation on the tip of the vizigo sheath.The bwi product analysis lab became aware of the a perforation on the tip of the vizigo sheath on 21-jul-2025 and have also assessed this returned condition as reportable.
Additional Manufacturer Narrative
The product investigation was reopened to clarify/correct the investigation findings which resulted in the following updated investigation on 27-jan-2026.The device evaluation details.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation on 19-jun-2025.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual analysis revealed a perforation on the tip of the vizigo sheath, the perforation could be the result of the handling of the device during the procedure, since the customer's report regarding, ¿the vizigo could not be inserted in la.When the sheath was removed from the cardiac cavity, the tip of the sheath was found to be dented.¿ the outer diameter was measured and it was found within specifications.A device history review was performed for the finished device batch number, and no internal actions were identified.The tip issue of ¿intracardiac resistance¿ reported by the customer was confirmed.The potential cause of the perforation on the tip could be related to the manipulation of the device during the procedure; however, this could not be conclusively determined.The sheath instructions for use (ifu) contain the following recommendations: use fluoroscopy and/or intracardiac ultrasound to monitor the advancement of the catheter and removal of the catheter from the sheath.Move the catheter carefully to avoid cardiac damage, perforation, or tamponade.If resistance is encountered, do not use excessive force to advance or withdraw the catheter through the sheath.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer¿s reference number: (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: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 22855923
• Report Number: 2029046-2025-02767
• Device Sequence Number: 8373490
• Product Code: DYB
• UDI-Device Identifier: 10846835026269
• UDI-Public: (01)10846835026269(17)260904(10)60000499
• 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
• Report Date (Section B): 02/13/2026

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 Expiration Date: 09/04/2026
• Device Catalogue Number: D138505
• Device Lot Number: 60000499
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2025
• Supplement Date Received by Manufacturer: 01/27/2026
• Initial Report FDA Received Date: 08/20/2025
• Supplement Report FDA Received Date: 02/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM (FOR JAPAN); P500 ULTRASOUND MACHINE; UNK CABLE; UNK ECHO VIDEO CABLE
• Patient Sex: Unknown