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

Model Number FG540000

Device Problems Computer Software Problem (1112); Device Emits Odor (1425); Communication or Transmission Problem (2896)

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

Event Date 05/12/2023

Event Type  malfunction  

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).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a burning/smoke smell was emitted from the unit.It was reported that was setting up for a procedure, they received error 987: "temperature reading out of range" and error 993: "power card sensor reading out of range".The caller reported that it also smelled like something was burning.The caller reported that they believed that the smell was coming from the signal processing unit (spu).To troubleshoot the caller turned off the spu and patient interface unit and plugged them back in without resolution.They used an spu from another room, the issue was resolved, and the procedure continued.Later, the caller continued to troubleshoot and they plugged the defective spu into another carto 3 system and the errors continued to appear.It is unknown what caused the issue.No signs of visible smoke but burning smell from the spu.Smelled like burning paint or plastic.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a burning/smoke smell was emitted from the unit.It was reported that was setting up for a procedure, they received error 987: "temperature reading out of range" and error 993: "power card sensor reading out of range".The caller reported that it also smelled like something was burning.The caller reported that they believed that the smell was coming from the signal processing unit (spu).Device evaluation details: it was confirmed that the reported issue was resolved by replacing faulty spu with a new one that was delivered to the account.The system is operational.Replaced faulty spu was sent to the manufacturer for investigation.The customer complaint was confirmed.During investigation was found that the spu had mechanical damage on the ecg card, and it causes a short circuit caused the burning signs and smell.The faulty spu ecg card was scrapped.The history of customer complaints reported during the last year associated with carto 3 system #(b)(4) was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system #(b)(4), and no internal actions related to the reported complaint condition were identified.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) please consider the previously reported h6.Device problem code of "computer software problem (a11)" as removed.

• 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: 17084358
• MDR Text Key: 316848845
• Report Number: 2029046-2023-01256
• 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: 06/07/2023

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 Model Number: FG540000
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/12/2023
• Initial Date FDA Received: 06/07/2023
• Supplement Dates Manufacturer Received: 03/12/2024
• Supplement Dates FDA Received: 04/03/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/25/2015
• 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