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 12/27/2021

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 occurred with no error message, no cardioversion and no patient movement.Initially it was reported, all of the catheters were jumping and shaking and then a map shift was noticed 8mm away from the shell.When hitting shift w, the electrodes looked like they were in a ball.Re-mapping was done to proceed with the case.There was no patient consequence reported.Additional information was received on 28-dec-2021.Issue may be due to patching error with patient, but indicated potential problem with vizigo catheter as well.Additional information was received on 29-dec-2021.Catheters no longer "balled up" after patching issue was resolved.Vizigo visualization was still slightly off; therefore, the biosense webster, inc.Field service representative requested pictures of ports.After review, with the information available, the map shift issue and the visualization issue were assessed as not mdr reportable.Additional information was received on 30-dec-2021.No error was displayed and the map shift was discovered because it visibly shifted.The issue was seen during ablation.The approximate difference in catheter location before and after the map shift was approximately 8 -12 mm.The physician did not perform cardioversion prior to the map shift and the patient did not move before detecting the shift.Since the additional information on 30-dec-2021 stated that there was no error message, no cardioversion and no patient movement, the map shift issue was reassessed to mdr reportable with the awareness date of 30-dec-2021.

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 additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Manufacturer Narrative

The investigation was completed on 14-jul-2022.It was reported that during atrial fibrillation ablation procedure with a carto® 3 system, all the catheters were jumping and shaking and then a map shift was noticed 8-12 mm away from the shell.When hitting shift w, the electrodes looked like they were "balled up".Re mapping was done to proceed with the case.The bwi representative indicated issue may be due to patching error with patient.The customer reported that no error messages were displayed by the system, map shift was visually detected.The physician didn't perform cardioversion neither did the patient move prior to the map shift.There was no patient consequence reported.It was reported that remap was done to resolve the reported map shift issue.The procedure was continued and completed without patient consequences.The system is ready for use.The issue was investigated.It was not possible to continue the investigation because partial data was sent and there is no recording.As a result, it was not possible to reproduce or analyze the issue.The root cause of the reported map shift issue was not determined.The complaint history of the system was reviewed.It was also reported that there was a problem with the visualization of the vizigo sheath.The visualization issue was resolved by rearranging the patches.The system is ready for use.A manufacturing record evaluation was performed for the carto 3 system # 29079, 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) during an internal review on (b)(6)-2022 a correction was noted to the 3500a initial report as in error omitted ¿h6.Medical device problem code¿ of ¿application program problem (a1102)¿.Therefore, processed.

• 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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13347519
• MDR Text Key: 289005397
• Report Number: 2029046-2022-00156
• 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: 08/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2022
• 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: 07/13/2022
• Was Device Evaluated by Manufacturer?: No
• 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; UNK_CARTO VIZIGO SHEATH