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 06/30/2022

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 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.(b)(4).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 ablation procedure with a carto® 3 system and there was no ecg signal.They did not have an ecg signal on carto and ep recording system (eprs) as soon as they started the patient interface unit (piu).They restarted the piu and the ecg signal came back (on carto and eprs) but disappeared again.They checked all cables, unplugged and re-plugged them but they still didn¿t have ecg signal.The patient was on the table.Additional information was received on the event.The patient was under propofol for like 30 minutes, from the time where the physician came in until he decided to postpone the procedure.In the physician¿s opinion, the cancelation of the procedure did not contribute to a death or a serious injury to the patient.The patient did not require extended hospitalization due to a medical condition caused by procedure cancellation, the procedure was successfully completed on the next morning.The physician did not have an intact ecg signal available to monitor patient heart rhythm (no ecg signal at all).The signal loss was observed on body surface only as the physician did not puncture, so no catheter was inserted.The procedure was completed the following day.The nursing staff found another ecg cable, they changed it and tested it on the patient, who was still there.It worked, but physician did not want to continue the procedure due to the time, it was already late.The absence of treatment issue was assessed as not mdr reportable.It was not life threatening; does not result in permanent impairment of a body function or permanent damage to a body structure; or does 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 described signal issue was assessed as mdr reportable.

Manufacturer Narrative

During an internal review on 26-jul-2022, it was assessed that this event occurred before the procedure.Additional information was received on 04-aug-2022 stating that they had a separate surface ecg (metek hemodynamic monitoring station).However, it is not connected with biosense webster, inc.Product.Therefore, a surface ecg of the patient was always available during sedation.Since the physician had a surface ecg available to monitor the patient¿s heart rhythm, this mitigates any risk involving the loss of signal on bwi equipment as the signal loss was not total.Therefore, the potential that this could cause or contribute to an adverse event was remote, and this event is no longer considered mdr reportable.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 15109215
• MDR Text Key: 304135922
• Report Number: 2029046-2022-01707
• Device Sequence Number: 1
• Product Code: DQK
• UDI-Device Identifier: 10846835000870
• UDI-Public: 10846835000870
• Combination Product (y/n): N
• PMA/PMN Number: K133916
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 07/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/29/2016
• 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 EP RECORDING SYSTEM.