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

Catalog Number FG540000

Device Problems Computer Software Problem (1112); Device Emits Odor (1425); Fitting Problem (2183); Communication or Transmission Problem (2896)

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

Event Date 01/18/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and an unexpected/burning smell was noticed.The operator claimed that there was a burning smell from the patient interface unit (piu).There was no visible sign of smoke.Just an unexpected smell.Additional information was received on 1 feb-2024.It was reported that ¿the smell obviously did not come from the piu but the station¿.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: pc-(b)(4).

Manufacturer Narrative

It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and an unexpected/burning smell was noticed.The operator claimed that there was a burning smell from the patient interface unit (piu).There was no visible sign of smoke.Just an unexpected smell.Additional information was received on 1 feb-2024.It was reported that ¿the smell obviously did not come from the piu but the station¿.No adverse patient consequence was reported.Device evaluation details: the bwi field service engineer (fse) visited the account and confirmed that the issue was resolved by replacing the dc/dc card with another one that was delivered to the customer.The suspected dc/dc was sent to the manufacturer for investigation.It was found that the dc/dc card had a faulty component that caused the reported issues.The card was repaired, and the issue resolved.It was also reported that the map port was physically damaged on the piu backplane card.The fse confirmed that the map port had only some scratches in white plastic, golden sockets worked according to specification.The history of customer complaints reported during the last year associated with carto 3 system #11470 was reviewed.No similar complaints were found.The manufacturing record evaluation was performed on carto 3 system #11470, 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 reference number: (b)(4) during an internal review on 02-apr-2024, it was noted that the h 6.Medical device problem code of ¿communication or transmission problem (a13)¿ does not capture the reported event and therefore, does not apply.As such, this code was removed.

Manufacturer Narrative

E1.Initial reporter phone (b)(6).On 14-feb-2024, additional information was received, and the physician¿s contact details were provided.Therefore, section e was updated.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: 18681035
• MDR Text Key: 335411717
• Report Number: 2029046-2024-00450
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/24/2024

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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/18/2024
• Initial Date FDA Received: 02/09/2024
• Supplement Dates Manufacturer Received: 02/14/2024; 04/02/2024
• Supplement Dates FDA Received: 03/08/2024; 04/24/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/26/2010
• 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