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

Catalog Number FG540000C

Device Problems Signal Artifact/Noise (1036); Use of Device Problem (1670)

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

Event Date 01/29/2023

Event Type  malfunction  

Manufacturer Narrative

The hardware investigation has begun but it has not been completed at this time.This report is being submitted pursuant to the provisions of 21 cfr, part 803.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).

Event Description

The body surface signal cannot be transmitted to the patient interface unit (piu), and there is no signal on the body surface.The usage count of this body surface (bs) cable on the machine has exceeded 100 times.The machine software version provided by the repair applicant is v6, and the specific software version is not available.The physician didn't have any intact ecg signal available to monitor patient heart rhythm.The signal loss was identified on the carto® and recording system.The bs ecg cable was replaced.This was not an out-of-box failure.No patient consequences were reported.Bs ecg cable used over 100 times is not mdr-reportable.Signal loss on all bs and ic (intracardiac) channels and on all external systems is mdr-reportable.

Manufacturer Narrative

On 29-mar-2023, the product investigation was completed.The body surface signal cannot be transmitted to the patient interface unit (piu), and there is no signal on the body surface.The usage count of this body surface (bs) cable on the machine has exceeded 100 times.The machine software version provided by the repair applicant is v6, and the specific software version is not available.The physician didn't have any intact ecg signal available to monitor patient heart rhythm.The signal loss was identified on the carto® and recording system.The bs ecg cable was replaced.This was not an out-of-box failure.No patient consequences were reported.Device evaluation details: company representative confirmed that the faulty bs ecg cable was replaced and the issue is resolved.The faulty bs ecg cable was requested for investigation in device manufacturer, but the company representative confirmed that the cable was destroyed according to the requirements of the hospital.System is operational.Due to the condition of the bs ecg cable, an internal action was opened.A manufacturing record evaluation was performed for the system 66674, 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).

• Brand Name: CN CARTO 3 SYSTEM (FOR CHINA)
• Type of Device: SIMILAR DEVICE FG540000, 510K # K042999
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16437525
• MDR Text Key: 310273688
• Report Number: 2029046-2023-00375
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FG540000C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 01/29/2023
• Initial Date FDA Received: 02/24/2023
• Supplement Dates Manufacturer Received: 03/29/2023
• Supplement Dates FDA Received: 04/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1