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

Catalog Number FG540000

Device Problems Signal Artifact/Noise (1036); Electrical /Electronic Property Problem (1198); Electrical Shorting (2926)

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

Event Date 03/14/2024

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.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.Manufacturer's reference number: (b)(4).Biosense webster manufacturer's reference number (b)(4) has 2 reports.1) manufacturer report number 2029046-2024-01177 for the octaray mapping catheter.2) manufacturer report number 2029046-2024-01178 for the carto 3 system (this current report).

Event Description

It was reported that a patient underwent a left-sided atrial flutter ablation procedure with a octaray mapping catheter and carto 3 system and there were signal issues.There was a current leakage error displayed on the carto 3 system.When the occurred, there was no available signal on all ecg (electrocardiogram) signals.Both bs (body surface) and ic (intracardiac) could not be tracked temporarily.The octaray catheter was inside of the patient's body when the signal issues began.The cables and catheters were disconnected.However, the current leakage error reoccurred on the octaray catheter as soon as it was connected.The error cleared when the catheter was disconnected.The 20 pole a and b ports were checked for visual damage but no visual damage was noted.A pentaray catheter was then used as the replacement and the issue resolved.It was also reported that the acl box displayed "anatomically off" on the carto 3 system.Patient was re-patched (unusually high on the anatomy) and the issue resolved.The procedure was ultimately completed without patient consequence.

• 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: 19081144
• MDR Text Key: 340588069
• Report Number: 2029046-2024-01178
• 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
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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?: No
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/10/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/11/2024
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: OCTARAY CATHETER; PENTARAY CATHETER; PRUCKA SYSTEM