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); Application Program Problem (2880)

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

Event Date 10/26/2021

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred with no error message, no patient movement and no cardioversion.The accuresp graph shifted when radio frequency ablation energy was being delivered, and the catheters started to move around erratically on the carto® 3 system.The physician noticed that a map shift occurred on the carto® 3 system as well, but there was no error displayed.The procedure continued with the accuresp graph and catheter issue persisting, and they edited the map as they went.There was no patient consequence reported.No error ¿ catheter projections within certain anatomic structures do not match their location in earlier portions of the procedure (indicating possible shift).Issue was noticed during ablating.Did not have a way of measuring the map shift.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.Normal workflow.The issues of the accuresp graph shifted and the catheter visualization were assessed as not mdr reportable.The potential risk that they could cause or contribute to a death or serious deterioration in state of health was remote.The map shift issue with no error message, no patient movement and no cardioversion was assessed as a mdr reportable issue.

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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.(b)(4).

Manufacturer Narrative

The investigation was completed on 15-dec-2021.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred with no error message, no patient movement and no cardioversion.The accuresp graph shifted when radio frequency ablation energy was being delivered, and the catheters started to move around erratically on the carto® 3 system.- a software defect was discovered that is being resolved.The physician noticed that a map shift occurred on the carto® 3 system as well, but there was no error displayed.-the issue was investigated.The study data was requested by the device manufacturer to investigate the issue.The bwi representative provided only partial data that was not enough to investigate the issue.Full study data was requested.The bwi representative reported that the data was not available as the workstation was replaced due to another issue.The workstation was reimaged and a result the data was erased.Therefore, further investigation of the map shift issue was not possible.Remote support was provided by the technical team and confirmed that the system performed as intended.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system 29079, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate the map shift issue.H6.Investigation conclusions code of ¿appropriate term/code not available¿ represents a software bug issue.Explanation of codes: -investigation findings: no device problem found (c19) / investigation conclusions: cause not established (d15) were selected as related to the customer¿s reported ¿map shift - no error message - no pt movement/cardioversion¿.-investigation findings: software problem identified (c10) / investigation conclusions: appropriate term/code not available (d17) / component code: computer software (g02008) were selected as related to the ¿accuresp graph shifted¿ and the ¿catheter visualization¿ issues.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 ; IS
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12808359
• MDR Text Key: 285405256
• Report Number: 2029046-2021-01972
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2021
• 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?: No
• Date Manufacturer Received: 12/15/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/23/2014
• 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 CATHETER