MAUDE Adverse Event Report: BIOSENSE WEBSTER INC WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY; CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING

Catalog Number	D135303
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/30/2023
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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.#(b)(4).
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a webster cs catheter with auto id technology and a odd silicone/plastic attachment at the tip of the catheter was found.It was reported they were struggling to advance webster cs catheter with auto id technology and upon pulling it out, they noticed an odd silicone/plastic attachment at the tip of the catheter.There was no patient consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.
Additional Manufacturer Narrative
On 30-jan-2024, the bwi product analysis lab received the complaint device for evaluation.The product 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 ref.# (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a cardiac ablation procedure with a webster cs catheter with auto id technology and a odd silicone/plastic attachment at the tip of the catheter was found.It was reported they were struggling to advance webster cs catheter with auto id technology and upon pulling it out, they noticed an odd silicone/plastic attachment at the tip of the catheter.There was no patient consequence.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.A visual inspection evaluation of the returned device was performed following bwi procedures.Visual analysis of the returned sample revealed a plastic foreign material attached to the tip of the device.For this reason, a fourier-transform infrared spectroscopy (ft-ir) analysis was requested and it was concluded that the foreign material is mainly composed of biological-based material.Presumably a tissue or fluid from the patient.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.As part of biosense webster¿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 ref.# pc-(b)(4).
Additional Manufacturer Narrative
Udi related data quality updates only.Correction to the initial mdr, incomplete udi was provided.Section d4.Primary udi number has been updated with full udi (b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.No: (b)(4).

• Brand Name: WEBSTER CS CATHETER WITH AUTO ID TECHNOLOGY
• Common Device Name: CATHETER, ELECTRODE RECORDING, OR PROBE, ELECTRODE RECORDING
• 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: 18145335
• Report Number: 2029046-2023-02660
• Device Sequence Number: 7502860
• Product Code: DRF
• UDI-Device Identifier: 10846835009972
• UDI-Public: (01)10846835009972(11)230221(17)260220(10)31011285M
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K080425
• 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,Followup,Followup,Followup
• Report Date (Section B): 11/15/2023

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: 02/20/2026
• Device Catalogue Number: D135303
• Device Lot Number: 31011285M
• 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: Not provided
• Supplement Date Received by Manufacturer: 01/30/2024; 02/19/2024; 07/09/2024
• Initial Report FDA Received Date: 11/15/2023
• Supplement Report FDA Received Date: 01/31/2024; 03/01/2024; 07/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2023
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown