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

Catalog Number	301803MS
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
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 and observed blood return from the hemostatic valve.Initially it was reported that the preface's hemostatic valve was damaged.Timing was 1 hour and 30 minutes after the start of use, after pulmonary vein isolation (pvi) cavotricuspid ishmus (cti) was completed, when reinserting the catheter to the left atrium (la).The issue was resolved by replacing the sheath to another new one.The procedure was completed without patient's consequence.There was no reverse bleeding or air contamination due to this.The hemostatic valve itself was not damaged.Additional information was received on 06-oct-2024 which clarified that the hemostatic valve got damaged, although it was not broken/cracked.The sheath was being used on the patient.No air entered the patient¿s body.No blood return was observed.Additional information was received on 04-nov-2024.Blood return from the hemostatic valve was confirmed.The hemostatic valve did not dislodge inside the hub nor outside the hub.The brim cap / did not become detached from the sheath.The approximate volume of blood that was lost was a few drops.However, the exact amount was unknown.Additional clarification was received on 06-nov-2024 stating that initially, it was reported that there was no blood return or air contamination, but on additional information, it was confirmed that blood return was observed.This event was originally considered non-reportable, however, bwi became aware on 04-nov-2024 of the blood return from the hemostatic valve and have reassessed the event as reportable.The awareness date for this record is 04-nov-2024.
Additional Manufacturer Narrative
An analysis of the product could not be performed since a physical sample was not received for evaluation.A manufacturing record evaluation was performed for the finished device number lot: 18223285 and no internal actions related to the complaint was 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.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).

• 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: 20768858
• Report Number: 2029046-2024-03788
• Device Sequence Number: 14552825
• Product Code: DYB
• UDI-Device Identifier: 10846835000030
• UDI-Public: (01)10846835000030(17)260630(10)18223285
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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
• Report Date (Section B): 11/24/2024

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: 06/30/2026
• Device Catalogue Number: 301803MS
• Device Lot Number: 18223285
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2024
• Initial Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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 CATHETER.; UNK RF NEEDLE.
• Patient Sex: Unknown