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

Model Number FG540000

Device Problem Image Orientation Incorrect (1305)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2020

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.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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where an unexplained map shift occurred.It was reported the pentaray splines would diapered with no errors on the carto® 3 system.Reset visualization and created a new map and the issue resolved but their was a map shift noticed right after.The catheter visualization issue was assessed as not reportable since there is no risk to the patient as a result of the procedure delay.Force was noticed where there shouldn't be and from a previous case with the same errors.It was decided to remap and compare the previous geometry noticing a huge difference.Map shift was seen during a remap after ablating.There was no cardio version or patient movement during the procedure.Less than 2 minutes of fluoro was used and turned off when mapping was done in both maps.The case was completed.There was no errors provided by the system.There was no report of patient harm.

Manufacturer Narrative

It was reported that a patient underwent cardiac ablation procedure with a carto® 3 system where an unexplained map shift occurred.It was reported the pentaray splines would diapered with no errors on the carto® 3 system.Reset visualization and created a new map and the issue resolved but their was a map shift noticed right after.Device evaluation details: the device evaluation has been completed.The pentaray visualization problem was resolved with reset visualization and creation of a new map.The study data was requested by the device manufacturer to investigate the map shift issue.However, the bwi representative informed that the workstation was replaced due to frequently reoccurring sw crashes caused at previous cases, and the recordings related to the case are not available anymore.The bwi representative provided only photo of the map shift.The photo was reviewed and it confirmed information initially reported.However, investigation of the map shift issue was not possible based on the provided information.The bwi representative confirmed that the issue has not reoccurred since.The system is operational.A manufacturing record evaluation was performed for the system (b)(6), 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 ref.#(b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: COMPUTER, DIAGNOSTIC, PROGRAMMABLE
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 33 technology drive; irvine CA 92618
• MDR Report Key: 10740801
• MDR Text Key: 213211918
• Report Number: 2029046-2020-01568
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2020
• 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
• Date Manufacturer Received: 11/18/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNK_PENTARAY; UNK_PENTARAY