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

Catalog Number	D7TCDL252RT
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As stated in the complaint form, the event date is unknown.As a result, the 1st day of the year has been entered as the event date under b3.Date of event.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).
Event or Problem Description
It was reported that a patient underwent an ablation procedure with a celsius¿ electrophysiology catheter and there is some of the blue plastic coating missing at the tip.The tip of the celsius¿ electrophysiology catheter should be straight, but this catheter the tip is bent.In addition, there is some of the blue plastic coating missing at the tip.No patient consequence.Additional information was received.The caller did not support this case.It was a case performed by the physician without support by the biosense webster, inc.Team.That is why the caller cannot provide the specific day of procedure.But the caller is sure that they performed the procedure only a few days before the caller received the catheter with the issue.There were no wires exposed.The tip was just bent like it was kind of pre-shaped, comparable for example like the cardiaguide is pre-shaped with an angle.As there was some of the plastic coating at the catheter tip missing, some of the electrodes were more exposed than they should be.The caller believes they saw the damage before insertion of the catheter.The caller already sent the catheter in and therefore, unable to take a picture.The catheter was not pre-shaped.The issue of there is some of the blue plastic coating missing at the tip was assessed as mdr reportable.
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 05-sep-2023.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 ablation procedure with a celsius¿ electrophysiology catheter.The tip of the celsius¿ electrophysiology catheter should be straight, but this catheter the tip is bent.In addition, there is some of the blue plastic coating missing at the tip.No patient consequence.The investigation was completed on 18-sep-2023.The device was returned to biosense webster (bwi) for evaluation.Visual inspection, microscopy examination, and tilt test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.No wires exposed were observed and the anchor window was observed correctly, no problem was observed with the tip.The customer referred that there was some of the blue plastic coating missing at the tip; however a microscopy examination was performed and the plastic coating was observed correctly.A tilt test was performed and the tip deviation was within the allowable range of 10 degrees of freedom.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.This product issue will be addressed through bwi's quality system.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: 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: 17595887
• Report Number: 2029046-2023-01824
• Device Sequence Number: 7421558
• Product Code: LPB
• UDI-Device Identifier: 10846835000382
• UDI-Public: 10846835000382
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/13/2023

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: 05/31/2026
• Device Catalogue Number: D7TCDL252RT
• Device Lot Number: 31077817M
• 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: 07/25/2023
• Supplement Date Received by Manufacturer: 09/05/2023; 09/18/2023
• Initial Report FDA Received Date: 08/22/2023
• Supplement Report FDA Received Date: 09/12/2023; 10/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2023
• 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
• Patient Sex: Unknown