MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Catalog Number	D7TCFL252RT
Medical Device Problem Codes	Positioning Failure (1158); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a cardiac ablation procedure with a celsius¿ electrophysiology catheter.After connecting the catheter to a st.Jude medical radiofrequency (rf) generator and recording system, the physician inserted the catheter into the patient.Something abnormal was seen on the xray so the physician removed the catheter from the patient.The physician deflected the catheter, and the curve appeared abnormal.When checking the catheter closely, it appeared to be defective.The catheter is not coated and wires can be seen.There were no lifted nor sharp rings and there was no resistance during insertion and removal of the catheter.The issue with the curve of the catheter was assessed as not mdr reportable.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The wires exposed issue is mdr reportable.
Additional Manufacturer Narrative
The product has not returned for analysis, however, a picture was provided by the customer.Evaluation is still in progress.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.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 photo analysis was completed on 12-oct-2023.It was reported that a patient underwent a cardiac ablation procedure with a celsius¿ electrophysiology catheter.After connecting the catheter to a st.Jude medical radiofrequency (rf) generator and recording system, the physician inserted the catheter into the patient.Something abnormal was seen on the xray so the physician removed the catheter from the patient.The physician deflected the catheter, and the curve appeared abnormal.When checking the catheter closely, it appeared to be defective.The catheter is not coated and wires can be seen.There were no lifted nor sharp rings and there was no resistance during insertion and removal of the catheter.Photo analysis details: a picture was received for evaluation following biosense webster's procedures.The pictures provided by the customer does not provide sufficient information related to the deflection issue reported by the customer.Therefore, no results can be obtained from it.Also, the coating issue reported by the customer is related to the anchor window and this is part of the design of the catheter.No anomalies were observed on the catheter.A manufacturing record evaluation was performed for the finished device lot 30890253m, and no internal actions related to the reported complaint were identified.The customer complaint was not confirmed based on the picture received.The device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate to find the root cause of the complaint.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.H6.Investigation findings code of "appropriate term/code not available (c22)" represents photo/video analysis.Manufacturer's reference number: (b)(4).

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 17765937
• Report Number: 2029046-2023-02108
• Device Sequence Number: 17944550
• Product Code: LPB
• UDI-Device Identifier: 10846835000405
• UDI-Public: 10846835000405
• Combination Product (Y/N): N
• Initial Reporter Country: LE
• PMA/510(K) Number: P950005
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/06/2023

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: 08/19/2025
• Device Catalogue Number: D7TCFL252RT
• Device Lot Number: 30890253M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/24/2023
• Supplement Date Received by Manufacturer: 10/12/2023
• Initial Report FDA Received Date: 09/18/2023
• Supplement Report FDA Received Date: 11/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2022
• 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: CORDIS INTRODUCER SHEATH, 8FR, 0.38X11 CM; ST. JUDE MEDICAL RF GENERATOR
• Patient Sex: Unknown