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

Catalog Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Poor Quality Image (1408)

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

Event Date 08/16/2023

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.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.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 an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the caller that visualization issues of multiple catheters occurred during the procedure.The caller noted that multiple catheters were flickering on the carto® 3 system.The caller stated that the optrell catheter splines would disappear.To troubleshoot, the bwi representative reset the catheter visualization and the catheter visualization issue resolved.However, during the post mapping portion of the procedure, the bwi representative noted that a map shift had occurred.The case was continued using the new map.After the procedure, the caller noted that the back patient placement was adequate and the grounding pads were placed in the appropriate area.On (b)(6) 2023, additional information was received indicating there were no errors the entire case.When trying to complete a post voltage map after ablating, optrell splines we're not appearing.I reset visualization matrix and that is when we noticed a map shift.Map shifted up by several millimeters.No cardio version.Patient was under general anesthesia and did not move.This event was originally considered nonreportable, however, on (b)(6) 2023, bwi became aware of additional information which indicated there was no patient movement or cardioversion and have reassessed the event as reportable.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a map shift issue occurred.It was reported by the caller that visualization issues of multiple catheters occurred during the procedure.The caller noted that multiple catheters were flickering on the carto® 3 system.The caller stated that the optrell catheter splines would disappear.To troubleshoot, the bwi representative reset the catheter visualization and the catheter visualization issue resolved.However, during the post mapping portion of the procedure, the bwi representative noted that a map shift had occurred.The case was continued using the new map.After the procedure, the caller noted that the back patient placement was adequate and the grounding pads were placed in the appropriate area.On 19-aug-2023, additional information was received indicating there were no errors the entire case.When trying to complete a post voltage map after ablating, optrell splines we're not appearing.I reset visualization matrix and that is when we noticed a map shift.Map shifted up by several millimeters.No cardio version.Patient was under general anesthesia and did not move.Device evaluation details: it was confirmed by the bwi representative that upon resetting the catheter visualization, the catheter visualization issue resolved.Damage was seen on both patch cables.A replacement patch unit was provided to the account and the issue resolved.The system is operational.Then it was also reported that during the post mapping portion of the procedure, a map shift had occurred.The issue was investigated by the manufacturer.It was found that the map shift resulted from working with high metal levels below warning limits.According to carto 3 instructions for use, (p.N.Ug-5400-0072h, rev.P02): "when the relative position between the patches remains the same but the position of the heart relative to the back patches has changed (for example, after repositioning the patient's head on a pillow or moving the patient's arm without changing the patient's position on the mattress, or after the patient is cardioverted), the system will not give a warning and an incorrect map (map shift) might be generated." the history of customer complaints reported during the last year and associated with carto 3 system #(b)(6) was reviewed.0 similar additional complaints were found.A manufacturing record evaluation was performed for the carto 3 system # (b)(6), and no internal action related to the reported complaint condition were identified.Explanation of codes: investigation findings: no device problem found (c19) / investigation conclusions: cause traced to user (d11) / were selected as related to the map shift issue.Investigation findings: no device problem found (c19) / investigation conclusions: cause not established (d15) were selected as related to the visualization issues.Investigation findings: mechanical problem identified (c07) / investigation conclusions: cause traced to component failure (d02) / component code: hub (g02021) were selected as related to the damaged cables.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4) correction: the following information was inadvertently omitted from section b5.Event description of the 3500a initial medwatch: "it was reported that damage seen on both patch cables." additionally, the h6.Medical device problem code of ¿electrical /electronic property problem (a07)¿ was inadvertently omitted from the 3500a initial mdr.It has been added now.

• 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: 17760862
• MDR Text Key: 323588167
• Report Number: 2029046-2023-02094
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/21/2023

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: 08/19/2023
• Initial Date FDA Received: 09/15/2023
• Supplement Dates Manufacturer Received: 11/02/2023
• Supplement Dates FDA Received: 11/21/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/27/2010
• 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: THMCL SMTCH SF BID, TC, D-F; UNK_CARTO VIZIGO SHEATH; UNK_OPTRELL MAPPING CATHETER