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

Catalog Number D7TDL252RT

Device Problems Signal Artifact/Noise (1036); Material Deformation (2976)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter and the distal electrode¿s plastic padding was frayed.It was reported there were no issues when the celsius¿ electrophysiology catheter was connected to the smartablate generator.When the physician inserted the catheter into the patient¿s body we had severe noise on the distal electrode so much so that the distal electrode¿s electrograms weren¿t distinct and visible.They tried to detect if there was any electromagnetic interference but everything seemed fine.They checked the gain and the selected settings on the recording system but everything seemed fine.They replaced the catheter¿s cable with a new one but the problem was not resolved.Afterwards, we removed the catheter from the patient¿s body to visually inspect the catheter¿s tip.They detected that the distal electrode¿s plastic padding was frayed and also the distal electrode seemed scratched.Finally, we replaced the ablation catheter with a new one and the problem eventually has been solved.The procedure continued without any further incident and no harm to the patient.Additional information received indicated the noise was observed on ic channels of the recording system.The physician had an intact ecg signal available to monitor the patient' s heart rhythm both on the recording system and the defibrillator.The customer¿s reported noise issue is not considered to be an mdr reportable malfunction since the risk to the patient is low.The physician inserted the ablation catheter sheathless.The insertion tool was used during the procedure.The physician didn't feel any resistance while introducing the catheter inside the patient' s body.

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.# pc-(b)(4).

Manufacturer Narrative

On 1-apr-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.Additionally, the manufactured date and expiration date have been provided.Therefore, fields d4.Expiration date and h4.Device manufacture date have been populated.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a celsius¿ electrophysiology catheter and the distal electrode¿s plastic padding was frayed.It was reported there were no issues when the celsius¿ electrophysiology catheter was connected to the smartablate generator.When the physician inserted the catheter into the patient¿s body we had severe noise on the distal electrode so much so that the distal electrode¿s electrograms weren¿t distinct and visible.They tried to detect if there was any electromagnetic interference but everything seemed fine.They checked the gain and the selected settings on the recording system but everything seemed fine.They replaced the catheter¿s cable with a new one but the problem was not resolved.Afterwards, we removed the catheter from the patient¿s body to visually inspect the catheter¿s tip.They detected that the distal electrode¿s plastic padding was frayed and also the distal electrode seemed scratched.Finally, we replaced the ablation catheter with a new one and the problem eventually has been solved.The procedure continued without any further incident and no harm to the patient.Device evaluation details: the device was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device, additionally, no foreign material was observed and no damage to the electrodes or any other portion or component of the device was detected.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The issues reported by the customer could not be confirmed during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.The instructions for use contain the following recommendation: electromagnetic interference (emi) produced by the biosense webster ® celsius¿thermocool® diagnostic/ablation deflectable tip catheter when used in conjunction with a rf generator during normal operation may adversely affect the performance of other equipment.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.# (b)(4).

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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: 18956741
• MDR Text Key: 338552133
• Report Number: 2029046-2024-00973
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835000412
• UDI-Public: 10846835000412
• Combination Product (y/n): N
• Reporter Country Code: GR
• PMA/PMN Number: P950005/S1
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: D7TDL252RT
• Device Lot Number: 31067501M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/05/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNKNOWN CATHETER CABLE.; UNKNOWN RECORDING SYSTEM.; UNK_SMARTABLATE GENERATOR.