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

Model Number FG540000

Device Problems Display or Visual Feedback Problem (1184); Electrical /Electronic Property Problem (1198); Computer Operating System Problem (2898); Appropriate Term/Code Not Available (3191)

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

Event Date 10/07/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(4) 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 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.(b)(4).

Event Description

It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a carto® 3 system and a map shift issue occurred.During the procedure, an error was displayed stating that there was a defective back patch cable: "error 1006" and the back patch cable could not be seen.It was also reported that there was a 4 - 5 seconds of delay on mapping.The system had to be restarted several times.There was no error provided.The issue was seen during ablating.The approximate difference in catheter location before and after map shift was about 2 cm.The patient did not move, and no cardioversion was done.The patient was under general anesthesia for about 2 hours.A transseptal puncture was performed prior to the case cancellation.In the physician¿s opinion, the cancellation of the procedure did not contribute to a death or a serious injury to the patient.It is unknown if the patient required extended hospitalization due to a medical condition caused by the procedure cancellation.There were no patient consequences.

Manufacturer Narrative

The hardware investigation was completed on 23-may-2022.It was reported that a patient underwent a premature ventricular contraction (pvc) ablation procedure with a carto® 3 system and a map shift issue occurred.During the procedure, an error was displayed stating that there was a defective back patch cable: "error 1006" and the back patch cable could not be seen.It was also reported that there was a 4 - 5 seconds of delay on mapping.The system had to be restarted several times.There was no error provided.The issue was seen during ablating.The approximate difference in catheter location before and after map shift was about 2 cm.The patient did not move, and no cardioversion was done.The patient was under general anesthesia for about 2 hours.A transseptal puncture was performed prior to the case cancellation.In the physician¿s opinion, the cancellation of the procedure did not contribute to a death or a serious injury to the patient.It is unknown if the patient required extended hospitalization due to a medical condition caused by the procedure cancellation.There were no patient consequences.Hardware investigation details: the bwi field service engineer (fse) visited the account and was unable to duplicate the issues.All anti-tachycardia pacing (atp) tests passed successfully.The issue was investigated, and it was found that the reported map shift was due to patient movement.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 associated with carto 3 system #11657 was reviewed.No similar complaints were found.A manufacturing record evaluation was performed for the finished device 11657 number, and no internal action related to the complaint was found during the review.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12732006
• MDR Text Key: 282401154
• Report Number: 2029046-2021-01859
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: IS
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2021
• 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: 05/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2010
• 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