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

Model Number D7BTCDL252RT

Device Problems Product Quality Problem (1506); High Readings (2459); Material Split, Cut or Torn (4008)

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

Event Date 09/20/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an ablation procedure with a celsius¿ electrophysiology catheter and it was observed that the catheter did not have a coating on the distal portion.The catheter does not have a coating on the distal portion, so it did not mark impedances or it marked high impedances.The surgery was delayed 10 minutes due to the reported event.The catheter was changed.The procedure was successfully completed.There were no patient consequences reported.Additional information was received.The material was closed when received at the facility.The fault is identified when using it.Sheath was not used.The device was used on the patient.In physician¿s opinion, the delay did not contribute to a death or a serious injury to the patient.Intervention was not required due to the delay.Ablation could not be given.Temperature was 50, watts 35, and high impedance.Additional follow up has been requested to clarify event description and regarding response to fragments question of, ¿if yes, were they removed easily without additional intervention? yes,¿.However, no further information has been made available.With the information available, the issue of the ¿catheter did not have a coating on the distal portion¿ was assessed conservatively as mdr reportable.The high impedance issue was assessed as not mdr reportable.The potential that it could cause or contribute to a death, serious injury, or other significant adverse event, was remote.

Manufacturer Narrative

Since the clarification is still pending on the issue of ¿the catheter did not have a coating on the distal portion¿, we have assessed the (b)(4).The bwi product analysis lab received the device for evaluation on 07-oct-2022.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 4.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).

Manufacturer Narrative

In the 3500a initial it was reported, ¿since the clarification is still pending on the issue of ¿the catheter did not have a coating on the distal portion¿, we have assessed the h6.Medical device problem code as ¿material split, cut or torn (a0414)¿.With the information available, the issue of the ¿catheter did not have a coating on the distal portion¿ was assessed conservatively as mdr reportable.¿ additional information was received on 19-oct-2022 providing clarification on the reported issue and there were never any exposed wires.The catheter was sent for analysis physically.Therefore, since there were no exposed wires, the issue which was initially assessed conservatively mdr reportable for ¿the catheter did not have a coating on the distal portion¿ was reassessed to not mdr reportable for cosmetic damage.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, was remote.Therefore, updated the h6.Medical device problem code to ¿product quality problem (a0201)¿.Manufacturer's reference number: (b)(4).

• Brand Name: CELSIUS¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15636816
• MDR Text Key: 306941349
• Report Number: 2029046-2022-02576
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835005219
• UDI-Public: 10846835005219
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: P950005/S2
• 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
• Report Date: 11/16/2022

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
• Device Operator: Health Professional
• Device Model Number: D7BTCDL252RT
• Device Catalogue Number: D7BTCDL252RT
• Device Lot Number: 30691100M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/20/2022
• Initial Date FDA Received: 10/20/2022
• Supplement Dates Manufacturer Received: 10/19/2022
• Supplement Dates FDA Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/02/2021
• 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 BRAND CATHETER; UNKNOWN BRAND GENERATOR