MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO® 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000K

Device Problem Fire (1245)

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

Event Date 06/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a cardiac ablation procedure with a carto¿ 3 system and a fire hazard issue occurred.At the time of v7 prime upgrade work, when the power cord was inserted into the work station, a short-circuiting sound was emitted, and after that, there was a burning smell and strange odor.The procedure was successfully completed without patient consequence.No further information is available.

Manufacturer Narrative

On 28-jun-2022, the product investigation was completed.It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and a fire hazard issue occurred.Device evaluation details: field service engineer confirmed that the customer was provided with a new workstation.Reported issue was investigated.The assignable cause found as nff- no fault found.No defective component finding & work station (ws) meet bwi specifications.Dell t5820 ws pass rework/re-install carto prime¿ ws system application v7.1.80.33.Relating dc-5404-300_08c - carto prime¿ ws preparation instructions, include running the ws & diagnostics program for 24 hours.The issue was not duplicated since the time it occurred.In addition, the history of customer complaints associated with this specific system was reviewed and it was found that the issue was not reported anymore.The system is ready for use.A manufacturing record evaluation was performed for the system #55199, 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).

• Brand Name: CARTO® 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• 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 ; IS
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12230297
• MDR Text Key: 263612964
• Report Number: 2029046-2021-01201
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/30/2022

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 Catalogue Number: FG540000K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/30/2021
• Initial Date FDA Received: 07/27/2021
• Supplement Dates Manufacturer Received: 06/28/2022
• Supplement Dates FDA Received: 06/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/04/2016
• 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