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

Catalog Number	301803MS
Medical Device Problem Codes	Break (1069); Device-Device Incompatibility (2919); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a preface sheath.The brk needle was advanced through the preface sheath and the dilator was sheared off.The sheath was replaced and the case continued.No patient consequence.A farapulse¿ generator was in use.Multiple attempts have been made to obtain clarification of this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.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
Additional information was received on 07-jul-2025.The resistance was between devices.No alteration on the shaft surface.The soft tip was not folded nor wrinkled on itself.The inner part of the sheath was sheered off.Minimal resistance with the sheath.It was a transseptal needle which caused the damage to the sheath and not a catheter or dilator.The needle was able to move within the sheath enough to sheer the inside of the sheath.The needle was stuck in the sheath was due to high resistance.The brk needle (not extra sharp version) was used.Damage was observed on the shaft.Due to the additional information received, updated the h6.Medical device problem code from break (a0401) to material protrusion / extrusion (a0411) and device-device incompatibility (a1702).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 06-aug-2025.An analysis of the product could not be performed since a physical sample was not received for evaluation.A device history record review was performed for the finished device lot number 18223285 and no internal action related to the complaint was found during the review.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.However, if the product is received at a later date, the investigation will be updated as applicable.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).

• 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: 22391321
• Report Number: 2029046-2025-02166
• Device Sequence Number: 8994666
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: (01)10846835000030(17)260630(10)18223285
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/29/2025

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: 06/30/2026
• Device Catalogue Number: 301803MS
• Device Lot Number: 18223285
• 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: 06/06/2025
• Supplement Date Received by Manufacturer: 07/07/2025; 08/06/2025
• Initial Report FDA Received Date: 07/02/2025
• Supplement Report FDA Received Date: 07/31/2025; 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/11/2023
• 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: UNK BRK NEEDLE.; UNK FARAPULSE¿ GENERATOR.; UNK NGEN SYSTEM.; UNK_CARTO 3.
• Patient Sex: Unknown