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

Model Number FG540000

Device Problem Fire (1245)

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

Event Date 08/26/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a fire hazard was reported.It was reported that it smelled like smoke or burning plastic.They were not using an octaray but the spu was connected to the carto® 3 system.They investigated the burning smell and discovered it was coming from the spu.Then it was noticed there was an error displayed on the carto® 3 system, error 987: spu temperature reading is out of range.Upon visual inspection there was no smoke coming out of the spu.They disconnected the spu and the smell went away.Case continued without further issue.There was no patient consequence.

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 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.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 a fire hazard was reported.It was reported that it smelled like smoke or burning plastic.They were not using an octaray but the spu was connected to the carto® 3 system.They investigated the burning smell and discovered it was coming from the spu.Then it was noticed there was an error displayed on the carto® 3 system, error 987: spu temperature reading is out of range.Upon visual inspection there was no smoke coming out of the spu.They disconnected the spu and the smell went away.Case continued without further issue.There was no patient consequence.Device evaluation details: the device evaluation has been completed.It was confirmed that the issue was resolved by replacing the faulty spu with another one that was delivered to the customer.The issue was resolved.The replaced spu was sent to the manufacturer for investigation and repair.The issue was confirmed.They found burning smell and overheating on spu power card.Also found errors in aquarium test and spu internal bit tests failed.Replacing of u9 in spu power card ea-5070-16f solved the reported issue.Finally, it was decided to send the power card to scrap and replace it with new card.The also replace ecg card and upgraded the digital.Spu retest all tests.The history of customer complaints reported during the last year associated with carto 3 system # (b)(6) was reviewed.There are no additional complaints with a similar reported issue.A manufacturing record evaluation was performed for the system # (b)(6), and no internal actions related to the reported complaint condition were identified.An internal action has been open to investigate this issue of increased errors related to the spu.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15481427
• MDR Text Key: 300547339
• Report Number: 2029046-2022-02308
• 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: 12/27/2022

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: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/26/2022
• Initial Date FDA Received: 09/24/2022
• Supplement Dates Manufacturer Received: 12/06/2022
• Supplement Dates FDA Received: 12/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/31/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNK_OCTARAY NAV.