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

Catalog Number	BD710DF282CT
Medical Device Problem Codes	Delivered as Unsterile Product (1421); Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 an atrial fibrillation (afib) ablation procedure with a webster cs and inside the sterile package, when opened, there was foreign material present.The catheter was replaced, and the case continued.No adverse patient consequence was reported.Additional information was received.It was reported that the foreign material looks like a tiny piece of cardboard or dust.It is very small in size and not embedded to the device.The issue was noticed before use and the device was not used on the patient.The package is unopened.
Additional Manufacturer Narrative
The biosense webster, inc.Product analysis lab received the device for evaluation.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) ablation procedure with a webster cs and inside the sterile package, when opened, there was foreign material present.The catheter was replaced, and the case continued.No adverse patient consequence was reported.Additional information was received.It was reported that the foreign material looks like a tiny piece of cardboard or dust.It is very small in size and not embedded to the device.The issue was noticed before use and the device was not used on the patient.The package is unopened.Device investigation details: the device was returned to johnson & johnson medtech (j&j) for evaluation.A visual inspection evaluation of the returned device was performed following j&j medtech procedures.Visual inspection of the returned sample revealed a foreign material inside the pouch and the seals were correctly closed.A fourier transform infrared spectroscopy (ftir) analysis was requested and it was determined that the foreign material was composed of cellulose or cellulose-based material.Due to this condition, a manufacturing investigation was requested.It was determined that this type of failure was related to the manufacturing process since the area where the mounting card were cleaned, was in a space on the shipping area, where there were card boxes and pallets spreading loose particles of cardboard or wood over the environment.It was noticed that there was a chance of contamination on the mounting card, when it was cleaned to take it into clean room.An internal corrective action was created to reduce contamination during the packaging process.A manufacturing record evaluation was performed for the finished device 31044806m number, and no internal action related to the reported complaint condition were identified.The sterilization compromised issue reported by the customer was confirmed.The root cause of this issue was related to the manufacturing process and an internal corrective action was assigned to reduce this type of failure.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 21665363
• Report Number: 2029046-2025-00876
• Device Sequence Number: 15392632
• Product Code: DRF
• UDI-Device Identifier: 10846835002409
• UDI-Public: (01)10846835002409(17)260423(10)31044806M
• 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 Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2025

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: 04/23/2026
• Device Catalogue Number: BD710DF282CT
• Device Lot Number: 31044806M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/24/2025
• Supplement Date Received by Manufacturer: 03/27/2025; 05/12/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 04/22/2025; 06/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/24/2023
• 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: ABBOTT GENERATOR.
• Patient Sex: Unknown