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

Model Number D7TCCL252RT

Device Problem Break (1069)

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

Event Date 11/28/2022

Event Type  malfunction  

Event Description

It was reported that an unknown patient underwent an unknown ablation procedure with a celsius¿ electrophysiology catheter.The tip was broken.Adverse event occurred on (b)(6)2022.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the device.There was no partial or total detachment.The tip dome was detached.No patient consequences were reported.Broken tip is mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).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: (b)(4).

Manufacturer Narrative

The biosense webster, inc.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).

Manufacturer Narrative

The device evaluation was completed on 16-feb-2023.It was reported that an unknown patient underwent an unknown ablation procedure with a celsius¿ electrophysiology catheter.The tip was broken.The damage did not result in any lifted or sharp rings.There was no resistance or difficulty during insertion or removal of the device.There was no partial or total detachment.The tip dome was detached.No patient consequences were reported.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.Visual analysis revealed no damage or anomalies on the device.The anchor window was in good conditions.No internal components were exposed.A manufacturing record evaluation was performed for the finished device 30540320m number, and no internal actions related to the reported complaint condition were identified.The tip issue reported by the customer could not be replicated during the product investigation.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 reference number: (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: 16017823
• MDR Text Key: 308544753
• Report Number: 2029046-2022-03199
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P950005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2024
• Device Model Number: D7TCCL252RT
• Device Catalogue Number: D7TCCL252RT
• Device Lot Number: 30540320M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/29/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1