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

Catalog Number FG540000C

Device Problems Signal Artifact/Noise (1036); Use of Device Problem (1670)

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

Event Date 02/22/2022

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.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 an ecg issue (noise carto, no external signal) occurred.Initially, it was reported that the body surface signal interference is high, and the usage count of this bs cable on the machine has exceeded 100 times.Additional information was received on 17-mar-2022 and it was reported that the physician did not have any intact ecg signal available to monitor patient heart rhythm.With this information, this event is now considered mdr reportable with an awareness date of 17-mar-2022.It was also reported that the signal interference (noise) was on bs.The signal interference (noise) was observed on carto® and recording system.During the signal interference the affected catheter was not inside the patient¿s body.No adverse patient consequence was reported.

Manufacturer Narrative

The hardware evaluation was completed on 13-jun-2022.It was reported that a patient underwent a cardiac ablation procedure with a carto® 3 system and an ecg issue (noise carto, no external signal) occurred.The physician did not have any intact ecg signal available to monitor patient heart rhythm.Hardware evaluation details: it was confirmed that the issue was resolved by replacing the faulty bs ecg cable with another one that was delivered to the customer.The suspected bs ecg cable was requested for investigation by the device manufacturer; however, the bwi field service engineer (fse) confirmed that the cable was discarded.The system is ready for use.The history of customer complaints reported during the last year associated with carto 3 system #(b)(6) was reviewed.No similar complaints were found.A manufacturing record evaluation (mre) was performed for the system 66454, and no internal actions related to the reported complaint condition were identified.Based on the mre, the h4.Device manufacture date has been updated.An internal corrective action has been opened to investigate the reported issue.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 20667 17; IS 2066717
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14116683
• MDR Text Key: 290152862
• Report Number: 2029046-2022-00811
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/08/2022

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: FG540000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/17/2022
• Initial Date FDA Received: 04/15/2022
• Supplement Dates Manufacturer Received: 06/13/2022
• Supplement Dates FDA Received: 07/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2018
• 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