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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Poor Quality Image (1408)

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

Event Date 10/27/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).Initial reporter phone: (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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred with no error message, no patient movement and no cardioversion.Initially it was reported that the heliostar balloon visualization issue and map shift occurred yesterday during the procedure.No patient consequence was reported.Managed to complete the procedure by using the x-ray system to check the balloon.Multiple attempts were made to obtain clarification to this complaint.However, no further information had been made available.With the information available, the map shift issue was assessed as not mdr reportable.The catheter visualization issue was also assessed as not mdr reportable.The potential risk that it could cause or contribute to a death or serious deterioration in state of health was remote.Additional information was received on the event on 17-nov-2021.There was no error message.The issue was seen during mapping and ablating.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.The map shift issue with no error message, no patient movement and no cardioversion was assessed as mdr reportable.The awareness date of this reportable malfunction is 17-nov-2021.

Manufacturer Narrative

It was reported that a patient underwent a paroxysmal atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift occurred with no error message, no patient movement and no cardioversion.In addition, there was a heliostar balloon visualization issue.The investigation was completed on 13-jan-2022.The issue was investigated.It was found that the reported map shift was caused due to high metal values during fast anatomical mapping acquisition.This is a known software issue, and an internal corrective action has been opened to investigate these issues as they relate to map shifts.The heliostar visualization was caused by the same issue.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.A manufacturing record evaluation was performed for the system 14233, 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: 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12974269
• MDR Text Key: 284825443
• Report Number: 2029046-2021-02154
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• 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
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/27/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FG540000
• Device Catalogue Number: FG540000
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2013
• 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: UNKNOWN BRAND X-RAY SYSTEM; UNK_HELIOSTAR CATHETER