MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; COMPUTER, DIAGNOSTIC, PROGRAMMABLE

Catalog Number FG540000

Device Problems Electrical /Electronic Property Problem (1198); Device Emits Odor (1425)

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

Event Date 10/16/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and smoke smell was present.It was reported that the bwi representative smelled smoke.The chest patch sensor cable just proximal to the connector to the patient interface unit (piu) was melted.The bwi representative request bwi field service engineer follow up and replace the yellow sensor cable.There were no visible fire or flames and no visible smoke.It was the smell of melted plastic that was present though.

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.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.(b)(4).

Manufacturer Narrative

It was reported, that a patient underwent an atrial fibrillation (afib) ablation procedure.With a carto® 3 system.And smoke smell was present.It was reported, that the bwi representative smelled smoke.The chest patch sensor cable just proximal to the connector to the patient interface unit (piu) was melted.The bwi representative, request bwi field service engineer follow up and replace the yellow sensor cable.There were no visible fire or flames and no visible smoke.It was the smell of melted plastic that was present though.Device evaluation details: it was confirmed, by the bwi representative.That the issue was resolved, by replacing the chest patch sensor cable with another one that was delivered to the customer.No tests or check was required for the carto 3 system.System functions and is operational at the same account.The system is ready for use.The suspected chest patch sensor cable was sent to the manufacturer for investigation.The cable was tested and passed all tests.There was no smoke smell from the cable/connector.The history of customer complaints reported, during the last year and associated with carto 3 system with serial#: (b)(6) was reviewed.No similar additional complaint was found.The manufacturing record evaluation was performed on carto 3 with serial#:(b)(6).And no internal actions related to the reported complaint condition were identified.The complaint investigation results will be used for monitoring and detecting statistical signals, per complaint trending and signal detection process.No capa is initiated, as the available information and results of the investigation, do not meet the capa triggers.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: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER (ISRAEL) LTD.; 4 hatnufah street; yokneam 20667 17; IS 2066717
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 18071954
• MDR Text Key: 327358398
• Report Number: 2029046-2023-02542
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/06/2023
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 05/06/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/26/2010
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1