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

Model Number FG540000

Device Problem Display or Visual Feedback Problem (1184)

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

Event Date 02/21/2023

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system and a mapshift no error message with no patient movement and no cardioversion issue occurred.It was reported that when they were ablating on anatomy, they received a "sudden" high force on the smarttouch surround flow catheter.To troubleshoot they attempted to re-zero the catheter with no resolution.The "force still did not align with the anatomy".The catheter cable was replaced and re-zeroing was tried again with no resolution.The catheter was then replaced and zeroing was attempted again with no resolution.They stated the physician believes there may have been a map shift but they are unsure.By using the pentaray catheter they were able to create a new shell which resolved the issue and the procedure continued.There was no patient consequence reported.Additional information was received on 27-feb-2023.There was no error provided by the system for the map shift.The force measured on the air bleeder suddenly skyrocketed and did not make sense with the map we had collected prior to ablation.The issue was seen during ablation.The approximate difference in catheter location before and after map shift was about 1-1.5 cm.The physician did not perform a cardioversion.There was no patient movement nor did the fluoro machine move during this time.There was definitely a change in the map.The anatomy was off and it was not wise to move forward with the case given the changes without doing a check of the anatomy.The force issue was assessed as non-reportable.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The map shift issue was originally considered non-reportable, however, bwi became aware of additional information stating there was no error provided by the system for the map shift, no cardioversion performed, and no patient movement and have therefore, reassessed the map shift issue as reportable.The reportable awareness date is 27-feb-2023.

Manufacturer Narrative

The investigation was completed on 23-apr-2023.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system.During the procedure, high force on the smarttouch surround flow catheter was received.The force did not make sense with the map that was collected prior to ablation.The approximate difference in catheter location before and after the map shift was about 1-1.5 cm.No patient movement and no cardioversion issue occurred.The biosense webster field service representative followed up with the biosense webster field representative and confirmed that the system exhibited signs of a damaged smarttouch surround flow catheter problem.They used with pentaray catheter and were able to create a new shell which resolved the issue.The study data, which related to the reported issue, was exported from the system and it was sent to the device manufacturer for investigation.It was confirmed that the map shift was caused by high metal interference.The system displayed a warning, but the user ignored this.Mapping with high and low metal levels result in non-consistent anatomy.The reported map shift was related to user error.There wasn¿t any problem with the system during the case.The complaint history of the system was reviewed and no more similar problems were found since the issue occurred.The system is ready for use.A manufacturing record evaluation was performed for the carto 3 system # 11764, 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16616753
• MDR Text Key: 312416592
• Report Number: 2029046-2023-00632
• 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: 05/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2023
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2011
• 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; UNKNOWN BRAND CATHETER; UNKNOWN BRAND CATHETER CABLE; UNKNOWN BRAND CATHETER CABLE; UNK_PENTARAY