MAUDE Adverse Event Report: Biosense Webster Inc CARTO 3; Computer, Diagnostic, Programmable

Catalog Number	FG540000
Medical Device Problem Code	Signal Artifact/Noise (1036)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/27/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that during an atrial fibrillation (afib) procedure when ablating, the ecg were saturated and unable to be read.It was managed to complete the case successfully.No patient consequences.The system manufacturer investigated the issue based on the study digital data.It was found that the indifferent electrode was placed to one of the back patch and ecg cables causing the ablation noise to be seen at the ecg signals.Issue is related to user error.The history of customer complaints reported during the last six years and associated with carto system # 34017 was reviewed.No similar additional complaint was found.The manufacturing record evaluation was performed on carto 3 #34017, 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
• Common Device Name: 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: katie seppa ; 31 technology dr; irvine, CA 92618 ; +1(513)337-8052
• MDR Report Key: 50356660
• Report Number: 3013300026-2026-02720
• Device Sequence Number: 20339514
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: (01)10846835000870(11)160613
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K252302
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Type of Report: Initial,Followup
• Report Date (Section B): 09/24/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: FG540000
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: 09/02/2026
• Initial Report FDA Received Date: 08/20/2026
• Supplement Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2016
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown