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

Catalog Number	D138503
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluation details: the product was returned to johnson & johnson medtech (j&j medtech) for evaluation.Visual inspection and irrigation test were performed following j&j medtech procedures.Visual analysis revealed that the access port with a three-way stopcock was cracked and had stress marks.The irrigation test was performed and a leakage was observed where the access port was cracked.A device history record was performed for the finished device batch number, and no internal actions were identified.The side port broken issue reported by the customer was confirmed.The potential cause of the cracked access port with a three-way stopcock could be related to the handling or manipulation of the sheath before the procedure, however, this could not be conclusively determined.The instructions for use (ifu) contain the following recommendations: use best practices for irrigation to minimize the potential for thrombus formation.Inject or saline flush only from the side port.Flush and maintain continuous saline.Using standard aseptic technique, remove the sheath from the package.Visually verify that the sheath is not damaged.As part of the 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 ref.# (b)(4).
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a vizigo and the sideport was broken.It was initially reported by the customer that the irrigation tubing from the vizigo was physically damaged.They changed the vizigo and the procedure was successfully completed.There were no fragments generated and no patient consequences.Additional information was received indicating that the side port was broken/cracked.No air entered the patient¿s body.

• 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: 22755193
• Report Number: 2029046-2025-02632
• Device Sequence Number: 12913288
• Product Code: DYB
• UDI-Device Identifier: 10846835016260
• UDI-Public: (01)10846835016260(17)260912(10)00002719
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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

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: 09/12/2026
• Device Catalogue Number: D138503
• Device Lot Number: 00002719
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/12/2024
• 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
• Patient Sex: Unknown