MAUDE Adverse Event Report: BIOSENSE WEBSTER INC CARTO 3 SYSTEM; SIMILAR DEVICE FG540000, 510K # K042999

Catalog Number FG540000J

Device Problems Pacing Problem (1439); No Pacing (3268)

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

Event Date 02/22/2021

Event Type  malfunction  

Manufacturer Narrative

Initial reporter phone: (b)(6).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: pc-(b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and an unwanted pacing issue and an emergency pacing issue occurred.Initially it was reported that during the pulmonary vein isolation, vvi was conducted, vpacing was in place when vvi was not in time.After the procedure, an experiment was conducted in a tank using a right ventricle catheter (decanav), but no abnormalities were found.The verification was completed considering that the cause on the stimu side was highly likely.The procedure was successfully completed without patient's consequence.Multiple attempts have been made to obtain clarification to this complaint.However, no further information had been made available.With the information available, the event was assessed as not mdr reportable for a ¿stimulation pacing issue¿.There was no risk to the patient.Additional information was received on 3/3/2021.The pacing leads were connected to the primary pacing port.The carto did not allow pacing and ablating at the same time.Unwanted pacing was delivered.The unwanted pacing issue provided in the additional information received was assessed as mdr reportable.The awareness date of this reportable issue is 3/3/2021.Additional information was received on 3/15/2021 which stated that this was an emergency pacing.The emergency pacing issue provided in the additional information received was assessed as mdr reportable.The awareness date of this reportable issue is 3/15/2021.A response was received on clarification of the event on 3/19/2021.When pacing was performed from the decanav in vvi mode from the stimulator, the timing of the pacing was different from the intended timing.However, in the field, it is thought that it was likely a problem or something to the stimulator.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) procedure with a carto® 3 system and an unwanted pacing issue and an emergency pacing issue occurred.Initially it was reported that during the pulmonary vein isolation, vvi was conducted, vpacing was in place when vvi was not in time.After the procedure, an experiment was conducted in a tank using a right ventricle catheter (decanav), but no abnormalities were found.The verification was completed considering that the cause on the stimu side was highly likely.The procedure was successfully completed without patient's consequence.Additional information was received on 3/3/2021.The pacing leads were connected to the primary pacing port.The carto did not allow pacing and ablating at the same time.Unwanted pacing was delivered.Additional information was received on 3/15/2021 which stated that this was an emergency pacing.The emergency pacing issue provided in the additional information received was assessed as mdr reportable.The awareness date of this reportable issue is (b)(6) 2021.A response was received on clarification of the event on (b)(6)2021.When pacing was performed from the decanav in vvi mode from the stimulator, the timing of the pacing was different from the intended timing.However, in the field, it is thought that it was likely a problem or something to the stimulator.Device investigation details: the reported issue was investigated by the device manufacturer.The issue cannot be reproduced by the device manufacturer.No additional investigation can be performed as the data related to the issue is not available.Based on the provided information, the investigation of the emergency and unwanted pacing issue was not possible.The history of customer complaints reported during the last year associated with carto 3 system #50067 was reviewed and one additional complaint similar to the reported issue was found.A manufacturing record evaluation was performed for the carto 3 system #50067, 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: pc-(b)(4).

• Brand Name: CARTO 3 SYSTEM
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 11599742
• MDR Text Key: 266388247
• Report Number: 2029046-2021-00465
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000J
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NON BWI-NIHON KOHDEN CORP PACING STIMULATOR; UNKNOWN BRAND DECANAV