MAUDE Adverse Event Report: BIOSENSE WEBSTER INC PREF.GUIDING SHEATH W/MULT.CRV; INTRODUCER, CATHETER

Catalog Number	301803M
Medical Device Problem Codes	Backflow (1064); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with preface sheath and the valve leaking and side port leaking issues were observed.The valve on the preface sheath was leaking and there was bleed back coming from the sheath.They exchanged the preface sheath and the issue was resolved and the case was continued.There was no patient consequence reported.Additional information was received.Physician stated that the blood was leaking back out of the opening for the catheter insertion as well as side port.Unknown if the hemostatic valve dislodged.Unknown if the brim cap/hub became detached from the sheath.The sheath was being used on the patient, but it was exchanged right away after noticing the leakage.It was used in the patient under approximately 10 minutes.Air did not enter the patient¿s body.
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
The bwi product analysis lab received the device for evaluation on 20-jan-2025.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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
It was reported that a patient underwent an atrial fibrillation (afib) procedure with preface sheath and the valve leaking and side port leaking issues were observed.The device evaluation was completed on (b)(6)2025.The product was returned to johnson & johnson medtech for evaluation.It was sent to the device manufacturer for further investigation.Visual and functional analyses of the returned device were performed following johnson & johnson medtech procedures.Visual inspection of the device revealed no signs of damages on the sheath or dilator.The functional analysis performed did not detect leaks along the sheath body or valve.A device history record evaluation was performed and no internal actions related to the complaint were found during the review.The complaint reported by the customer was not confirmed, the hemostasis valve does not present any separation condition or damages.It is possible that procedural or handling factors contributed to the observed issues.Based on the findings, the analysis suggests that the failure is unlikely to be related to the manufacturing process.As part of johnson & johnson medtech 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 reference number:(b)(4).

• Brand Name: PREF.GUIDING SHEATH W/MULT.CRV
• 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: 21146898
• Report Number: 2029046-2025-00174
• Device Sequence Number: 15750522
• Product Code: DYB
• UDI-Device Identifier: 10846835000047
• UDI-Public: (01)10846835000047(17)270831(10)18363952
• 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): 03/13/2025

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 Catalogue Number: 301803M
• Device Lot Number: 18363952
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2024
• Supplement Date Received by Manufacturer: 01/20/2025; 03/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 01/28/2025; 03/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/03/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: HEART SPAN TRANSEPTAL; NGEN; UNK_CARTO 3
• Patient Sex: Unknown