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

Catalog Number	BD710FJ282CT
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent an atrial fibrillation (afib) procedure with a webster cs catheter.While opening up the webster cs catheter, observed the catheter contaminated with a human hair.Replaced the catheter to continue with the procedure.There was no patient consequence reported.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
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
Additional information was received on 17-apr-2025.The issue was noticed before use.The material was described as hair, brown or black in color and a few inches long.The device was not used on the patient.The bwi product analysis lab received the device for evaluation on 05-may-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 a webster cs catheter.While opening up the webster cs catheter, observed the catheter contaminated with a human hair.Replaced the catheter to continue with the procedure.There was no patient consequence reported.The device evaluation was completed on 07-jul-2025.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 that the pouch of the catheter was severely bent in different parts.During the inspection, a hair was detected inside the pouch.For this condition, a manufacturing meeting was requested and it was determined that this failure was related to the manufacturing process since in some of the finals filters, the correct process could have been omitted or performed improperly, thus causing contamination with organic material to pass unnoticed.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The sterilization issue reported by the customer was confirmed.The root cause of the failure was related to the manufacturing process.According to customer complaint records, no such incidents have occurred previously.Therefore, this is an isolated case caused by improper handling of hair covers and / or security glasses.The potential cause of the package condition could be related to the handling of the device during the shipping process; however, this can not be conclusively determined.The damage was not related to the reported event.As part of the johnson & johnson medtech quality process, all devices are manufactured, inspected, and released to approved specifications.Explanation of codes: -investigation findings: manufacturing process problem identified (c16) / investigation conclusions: cause traced to manufacturing (d03) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿the catheter contaminated with a human hair¿ issue.In addition, biosense webster inc.Analysis finding of the ¿manufacturing process¿ related.-investigation findings: sterilization problem identified (c1602) / investigation conclusions: cause traced to manufacturing (d03) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿the catheter contaminated with a human hair¿ issue.In addition, biosense webster inc.Analysis finding of the ¿sterilization¿ related.-investigation findings: operational problem identified (c13) / investigation conclusions: cause traced to manufacturing (d03) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿the catheter contaminated with a human hair¿ issue.In addition, biosense webster inc.Analysis finding of the ¿hair was detected inside the pouch¿ related.-investigation findings: packaging compromised (c160501) / investigation conclusions: cause not established (d15) / component code: packaging (g04094) were selected as related to the customer¿s reported ¿the catheter contaminated with a human hair¿ issue.In addition, biosense webster inc.Analysis finding of the ¿pouch of the catheter was severely bent¿.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: 21937029
• Report Number: 2029046-2025-01385
• Device Sequence Number: 12735816
• Product Code: DRF
• UDI-Device Identifier: 10846835002423
• UDI-Public: (01)10846835002423(17)280130(10)31557875M
• 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): 07/31/2025

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: BD710FJ282CT
• Device Lot Number: 31557875M
• 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: 04/07/2025
• Supplement Date Received by Manufacturer: 04/17/2025; 07/07/2025
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/12/2025; 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2025
• 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: NGEN SYSTEM
• Patient Sex: Unknown