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

Model Number FG540000

Device Problems Signal Artifact/Noise (1036); Appropriate Term/Code Not Available (3191)

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

Event Date 07/29/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system and there was no ecg signal available to monitor the patient¿s heart rhythm.Initially it was reported that before the procedure, there's no signal when connected the cable when putting the cable in the right position.Using force on it could get a signal in few seconds but after, the signal disappeared.The procedure has been cancelled.The procedure cancellation was assessed as not mdr reportable for a patient event non serious event.It was not life threatening; did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The signal issue was assessed as not mdr reportable.The risk to the patient was low.Additional information was received on 18-aug-2022.The signal interference (noise) observed all ecg (body surface + intracardiac) channels.The signal interference (noise) was observed on carto® and recording system.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.The affected catheter was inside the patient¿s body.The additional information on 18-aug-2022 stating no ecg signal available to monitor the patient¿s heart rhythm was assessed as mdr reportable.The awareness date for this reportable issue is 18-aug-2022.

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 4.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).

Manufacturer Narrative

Additional information was received on 14-sep-2022.The signal loss was observed on the body surface (bs) only.The event occurred pre op.Additional information is being requested to clarify issue.The investigation evaluation was completed on 21-sep-2022.It was reported that a patient underwent a pulmonary vein isolation (pvi) ablation procedure with a carto® 3 system.It was reported that before the procedure, there's no signal when connected the cable when putting the cable in the right position.Using force on it could get a signal in few seconds but after, the signal disappeared.The procedure has been cancelled.Additional information was received.The signal interference (noise) observed all ecg (body surface + intracardiac) channels.The signal interference (noise) was observed on carto® and recording system.The physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm.The affected catheter was inside the patient¿s body.The biosense webster field service engineer on call received additional information about the occurrence.It was confirmed that the defective cable was the bs ecg cable.They tried with a different one after the case and had ecg signals.Replacement bs ecg cable was ordered.Technical services confirmed that the faulty bs ecg cable was replaced and the issue was resolved.The faulty bs ecg cable was requested for investigation by the device manufacturer, but technical services confirmed that the cable had been disposed of.System is operational.The complaint history of the system was reviewed.A manufacturing record evaluation was performed for the system 11679, and no internal actions related to the reported complaint condition were identified.An internal corrective action has been opened to investigate the bs ecg cable complaints.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

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 12-oct-2022, noted a correction to the 3500a follow-up #1 as it was missing the manufactured date under the h4.Device manufacture date field.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15279535
• MDR Text Key: 305536833
• Report Number: 2029046-2022-01962
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• Reporter Country Code: PL
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2010
• 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
• Treatment: UNKNOWN BRAND CABLE; UNKNOWN BRAND RECORDING SYSTEM