MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS; ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE

Catalog Number	BD710FJ282RTS
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster cs catheter.Foreign material was visualized within the sterile packaging of the catheter.The catheter was replaced to continue the procedure.There was no patient consequence reported.Additional information was received.The issue was noticed prior to use.It was a small brown or black fleck of possibly plastic or some other material.The material observed was loose.They decided not to use the device and it remained unopened with the material still inside.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on january 07, 2026.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.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
During an internal review on (b)(6) 2026, noted a correction to the 3500a follow-up #1 under "h11.Additional manufacturer narrative".It included, "the device evaluation was completed on 07-jan-2026." should have stated, "the device evaluation was completed on 09-jan-2026." 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 atrioventricular nodal reentrant tachycardia (avnrt) procedure with a webster cs catheter.Foreign material was visualized within the sterile packaging of the catheter.Additional information was received.It was a small brown or black fleck of possibly plastic or some other material.The material observed was loose.The device evaluation was completed on 07-jan-2026.The device was returned to johnson & johnson medtech (j&j medtech) for evaluation.Following j&j medtech procedures, a visual inspection of the returned device was performed.Visual inspection revealed no anomalies on the device.The original package of the device was not returned for analysis.A manufacturing record evaluation was performed for the finished device number, and no internal actions related to the reported complaint were identified.The foreign material reported could not be evaluated due to the packaging was not returned.A potential cause cannot be determined with the information available.As part of johnson & johnson medtech's 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: WEBSTER CS
• Common Device Name: ELECTRODE RECORDING CATHETER OR ELECTRODE RECORDING PROBE
• 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: 23998931
• Report Number: 2029046-2026-00053
• Device Sequence Number: 10184787
• Product Code: DRF
• UDI-Device Identifier: 10846835002430
• UDI-Public: (01)10846835002430(17)281016(10)31788017M
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K090898
• 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): 02/10/2026

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: BD710FJ282RTS
• Device Lot Number: 31788017M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2025
• Supplement Date Received by Manufacturer: 01/09/2026; 02/10/2026
• Initial Report FDA Received Date: 01/07/2026
• Supplement Report FDA Received Date: 02/02/2026; 02/10/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/17/2025
• 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_CARTO 3.
• Patient Sex: Unknown