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

Catalog Number FG540000

Device Problem Smoking (1585)

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

Event Date 08/28/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a loud noise was heard, some sort of explosion, and then some smoke coming out of the power supply.In the beginning, the whole carto system and the device were working normally (no errors or other issues).After 10-15 minutes, the event happened.There was no visible fire, flames, or smoke.Typical smell of like something was burning (maybe like plastic).No procedure involved.No adverse patient consequence was reported.

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 reference number: (b)(4).

Manufacturer Narrative

Additional information was received on 21-sep-2023 and the name of the healthcare practitioner was provided.Therefore, section e.Initial reporter section was updated.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 hardware investigation was completed on 25-dec-2023.It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a loud noise was heard, some sort of explosion, and then some smoke coming out of the power supply.In the beginning, the whole carto system and the device were working normally (no errors or other issues).After 10-15 minutes, the event happened.There was no visible fire, flames, or smoke.Typical smell of like something was burning (maybe like plastic).No procedure involved.No adverse patient consequence was reported.Hardware investigation details: it was confirmed that the issue was resolved by replacing the faulty power supply with another one that was delivered to the customer.The issue was resolved.The system is ready for use.Replaced power supply was sent to the manufacturer for investigation and repair.It was found that the failure analysis discovered multiple damaged components.The cause of the failure mode was from an excessive transient voltage applied to the unit, causing direct damage to the bulk capacitor, and collateral damage to the downstream components in the input circuitry.This unit is damaged beyond repair.The history of customer complaints reported during the last year associated with carto 3 system # 3036343 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the system #3036343, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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: 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: 17777295
• MDR Text Key: 323808641
• Report Number: 2029046-2023-02127
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 01/18/2024

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
• Device Operator: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/28/2023
• Initial Date FDA Received: 09/19/2023
• Supplement Dates Manufacturer Received: 09/21/2023; 12/25/2023
• Supplement Dates FDA Received: 10/17/2023; 01/18/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/24/2022
• 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
• Treatment: UNK DEVICE.