MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CELSIUS¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	D7BTCFL252RT
Medical Device Problem Codes	Manufacturing, Packaging or Shipping Problem (2975); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that prior to a patient's ablation procedure, the medical team discovered that the celsius¿ electrophysiology catheter they had intended to use had a physical abnormality at the catheter's distal end.The physician identified the following issue through the packing window: there was a ridge/hump at the catheter's tip (proximal to electrodes).The device was not used on the patient.No further details were provided.
Additional Manufacturer Narrative
The picture was reviewed and no root cause can be determined.However, it was reported that the device is available for analysis.Therefore, once the device is received by the bwi product analysis lab, the evaluation will be performed.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 reference number: pc-(b)(4).
Additional Manufacturer Narrative
On 1-feb-2024, the product investigation was completed.It was reported that prior to a patient's ablation procedure, the medical team discovered that the celsius¿ electrophysiology catheter they had intended to use had a physical abnormality at the catheter's distal end.The physician identified the following issue through the packing window: there was a ridge/hump at the catheter's tip (proximal to electrodes).The device was not used on the patient.No further details were provided.Device evaluation details: the device was returned to biosense webster (bwi) for evaluation.A visual inspection of the returned device was performed following bwi procedures.The device was returned in its original packaging.The packaging was opened, then the device was removed from the pouch to perform a visual inspection and no damage or anomalies were observed.A manufacturing record evaluation was performed for the finished device number lot 30977305m and no internal actions related to the complaint were found during the review.The issue reported by the customer was not confirmed, other issues or circumstances may have occurred during the usage of the device that compromised its performance.The issue identified by the customer is the anchor pin and that it is part of the catheter design.As part of the 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 reference number: (b)(4).
Additional Manufacturer Narrative
On 12-jan-2024, the bwi 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
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: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, 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: 18094586
• Report Number: 2029046-2023-02579
• Device Sequence Number: 5945253
• Product Code: DRF
• UDI-Device Identifier: 10846835005257
• UDI-Public: (01)10846835005257(11)230127(17)260126(10)30977305M
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P950005/S2
• 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,Followup,Followup
• Report Date (Section B): 02/23/2024

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: 01/26/2026
• Device Catalogue Number: D7BTCFL252RT
• Device Lot Number: 30977305M
• 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: 10/12/2023
• Supplement Date Received by Manufacturer: 01/12/2024; 02/01/2024; 07/11/2024
• Initial Report FDA Received Date: 11/08/2023
• Supplement Report FDA Received Date: 01/31/2024; 02/23/2024; 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/27/2023
• 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