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

Catalog Number SEE H10.

Device Problems Communication or Transmission Problem (2896); Electrical Shorting (2926)

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

Event Date 07/17/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system interface cable and a noise issue occurred.It was reported a current leakage error occurred.They started troubleshooting with the ecg cables because the noise came from there.This didn't change anything but when disconnecting and reconnecting the vizigo and changing cable, this seemed to be the problem.They removed ¿vizigo catheter¿ (after changing the cable) and used another one.Additional information received on 11-sep-2023 indicated there was also a signal noise issue observed on all channels.Signals were affected on both the carto 3 system and the recording system.The physician did not have other ecg/ekg signal available to monitor the patient¿s heart rhythm.This event was originally considered nonreportable, however, bwi became aware of additional information on 11-sep-2023 and have reassessed the event as reportable.

Manufacturer Narrative

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.D4.Catalog should be ¿unk_c3 interface cable ¿ therapeutic¿.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a carto® 3 system interface cable and a noise issue occurred.It was reported a current leakage error occurred.They started troubleshooting with the ecg cables because the noise came from there.This didn't change anything but when disconnecting and reconnecting the vizigo and changing cable, this seemed to be the problem.They removed ¿vizigo catheter¿ (after changing the cable) and used another one.Device investigation details: since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.However, if the product is received at a later date, the investigation will be updated as applicable.The lot number was reported as unavailable.As a result, the mre review cannot be conducted.Should the correct lot number be made available later, the complaint file will be reopened and an mre review will be performed and documented.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

• Brand Name: CARTO® 3 SYSTEM INTERFACE CABLE
• 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 INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17882995
• MDR Text Key: 325077162
• Report Number: 2029046-2023-02246
• Device Sequence Number: 1
• Product Code: DQK
• Combination Product (y/n): N
• Reporter Country Code: BE
• 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: 10/05/2023

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: SEE H10.
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/25/2023
• Initial Date FDA Received: 10/05/2023
• Supplement Dates Manufacturer Received: 11/03/2023
• Supplement Dates FDA Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 8.5F SHEATH WITH CURVE VIZ MDC.; UNKNOWN RECORDING SYSTEM.; UNK_CARTO 3.; UNK_LASSO NAV ECO.; UNK_SMART TOUCH BIDIRECTIONAL SF.