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

Catalog Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Communication or Transmission Problem (2896)

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

Event Date 03/05/2024

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a carto® 3 system and there was a map shift noticed.They were ablating on the septal side of the right inferior vein when they noticed it was more internal.They were doing the post map with the pentaray and the whole map had shifted itself.It was at least a 5mm map shift.There were ¿no learn new messages¿ and they did not have a map shift alert.No adverse patient consequence was reported.Additional information received indicated that the map shift was noticed because the initial lesion set was 1 cm away (internal) from the new lesion set on the posterior wall by the left veins.Right wide antral circumferential ablation (waca) geometry was off by about 1 cm as well.It was suspected that the map shift happened when the faulty ablation catheter and the cable were disconnected, and the new ablation catheter with a new cable were connected.There were no cardioversions and no patient movements noted.

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.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure which included a carto® 3 system and there was a map shift noticed.They were ablating on the septal side of the right inferior vein when they noticed it was more internal.They were doing the post map with the pentaray and the whole map had shifted itself.It was at least a 5mm map shift.There were ¿no learn new messages¿ and they did not have a map shift alert.No adverse patient consequence was reported.Additional information received indicated that the map shift was noticed because the initial lesion set was 1 cm away (internal) from the new lesion set on the posterior wall by the left veins.Right wide antral circumferential ablation (waca) geometry was off by about 1 cm as well.It was suspected that the map shift happened when the faulty ablation catheter and the cable were disconnected, and the new ablation catheter with a new cable were connected.There were no cardioversions and no patient movements noted.Hardware investigation details: an investigation was initiated by the manufacturer to assess the issue.It was found that the reported map shift issue was a result of mapping and ablating with high alternating metal levels.Issue is related to user error.System is operational.The history of customer complaints reported during the last year and associated with carto 3 system # 14639 was reviewed.No similar additional complaint was found.A manufacturing record evaluation was performed for the carto 3 system # 14639, and no internal actions related to the reported complaint condition were identified.Additionally, the manufactured date has been provided.Therefore, field h4.Device manufacture date has been populated.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19029652
• MDR Text Key: 339214283
• Report Number: 2029046-2024-01112
• 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: 05/08/2024

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: Not provided
• Initial Date FDA Received: 04/02/2024
• Supplement Dates Manufacturer Received: 04/15/2024
• Supplement Dates FDA Received: 05/09/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/24/2014
• 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: THMCL SMTCH SF BID, TC, D-F; THMCL SMTCH SF BID, TC, D-F; UNK BRAND CABLE; UNK_PENTARAY; UNK_SMARTABLATE GENERATOR