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

Catalog Number	301803M
Medical Device Problem Code	Difficult to Advance (2920)
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 preface sheath.In this case, the physician used the preface sheath since the femoral vein puncture, to do the cti ablation, and after the patient had a left side tachycardia.Therefore, the doctor needed to do a septal puncture with the preface sheath for the left side tachycardia.However, during the septal puncture, the physician could not push the sheath along with the dilator but only dilator could through to the left atrium (la).Therefore, they decided to change to a new sheath (preface) and it could go through.After, saw the edge at the end of the sheath was uneven and wrinkled.The procedure was not delayed due to the reported issue.The procedure was completed successfully.No patient consequence.
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 reference number: (b)(4).
Additional Manufacturer Narrative
H4.Device manufacture date has been added.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The investigation was completed on 12-jan-2026.An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record evaluation was performed for the finished device lot number and no internal action was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.Based on the information available, there is no indication that a design or manufacturing issue has caused the reported complaint condition.If the product is received at a later date, the investigation will be updated as applicable.During an internal review, noted a correction to the 3500a follow-up #1 under the h4.Device manufacture date.Reported as 15-jan-2025 and it should have been 03-jun-2024.Therefore, processed.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: PREFACE
• Common Device Name: INTRODUCER, CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: henry boden ; 31 technology dr; irvine, CA 92618 ; 9497882078
• MDR Report Key: 23458697
• Report Number: 2029046-2025-03684
• Device Sequence Number: 21084691
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)270531(10)18325704
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K982740
• 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
• Report Date (Section B): 01/19/2026

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 Catalogue Number: 301803M
• Device Lot Number: 18325704
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/27/2025; 01/12/2026
• Initial Report FDA Received Date: 11/03/2025
• Supplement Report FDA Received Date: 12/23/2025; 01/19/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/03/2024
• 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