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

Catalog Number	301803M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/31/2024
Type of Reportable Event	Malfunction
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).
Event or Problem Description
It was reported that a patient underwent a fascicular ventricular tachycardia procedure with a preface and the hub was totally separated.Preface sheath had a problem with closer valve.The action taken when the event occurred was to change the preface sheath.The procedure was delayed by 5 minutes.The procedure was successfully completed.There was no patient consequence reported.Additional information was received on 24-sep-2024.The hub was the section where the issue was observed.It was totally separated.Unknown if the hemostatic valve dislodged inside the hub.Unknown if the hemostatic valve dislodged outside the hub.The sheath was used on the patient.The patient did not require treatment.Blood return was observed.The volume of blood loss was unknown.This event was originally considered non-reportable, however, bwi became aware on 24-sep-2024 that the hub was totally separated and have reassessed the event as reportable.The awareness date for this record is 24-sep-2024.
Additional Manufacturer Narrative
The investigation was completed on 11-nov-2024.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 number 18172545, and no internal actions related to the complaint were found during the review.If the product is received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed 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: 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 20427524
• Report Number: 2029046-2024-03372
• Device Sequence Number: 12659826
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)251231(10)18172545
• Combination Product (Y/N): N
• Initial Reporter Country: PE
• 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
• Report Date (Section B): 11/20/2024

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: 12/31/2025
• Device Catalogue Number: 301803M
• Device Lot Number: 18172545
• 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: 09/24/2024
• Supplement Date Received by Manufacturer: 11/11/2024
• Initial Report FDA Received Date: 10/11/2024
• Supplement Report FDA Received Date: 11/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/04/2023
• 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: MERIT HEARTSPAN TRANSSEPTAL NEEDLE.
• Patient Sex: Unknown