MAUDE Adverse Event Report: BIOSENSE WEBSTER INC TX ECO CABLE; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number	D140102
Medical Device Problem Code	Device Emits Odor (1425)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/17/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a tx eco cable and a fumes smell issue occurred.It was reported that the physician smelled fumes at the patient¿s bedside, and the following errors on the ngen generator: 182: electrode - impedance too high.170: electrode - thermocouple disconnected, briefly appeared.279: rf cable disconnected (caller confirmed this cable was connected).276: carto® - electrode pacing warning-currently pacing electrode 1,2.The caller was advised to reboot the entire carto 3 system and exchange the catheter cable and tx eco cable, ngen was also rebooted.The study was reloaded, errors were resolved and case was continued.The caller called back and requesting a replacement tx eco cable that was replaced.They believed this was causing the fumes smell.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.The error messages which populated were assessed as non mdr reportable.The fumes smell issue was assessed as a mdr reportable malfunction under the tx eco cable.
Additional Manufacturer Narrative
E1.Initial reporter facility name: (b)(6) hospital.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.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation on 17-jun-2024.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
It was reported that a patient underwent a paroxysmal atrial fibrillation procedure with a tx eco cable.It was reported that the physician smelled fumes at the patient¿s bedside, and the following errors on the ngen generator: 182: electrode - impedance too high.170: electrode - thermocouple disconnected, briefly appeared.279: rf cable disconnected (caller confirmed this cable was connected).276: carto® - electrode pacing warning-currently pacing electrode 1,2.The caller was advised to reboot the entire carto 3 system and exchange the catheter cable and tx eco cable, ngen was also rebooted.The study was reloaded, errors were resolved and case was continued.The caller called back and requesting a replacement tx eco cable that was replaced.They believed this was causing the fumes smell.The device evaluation was completed on 23-aug-2024.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and cable testing were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Cable functionality was tested on carto 3 system while using a good known lab qdot micro catheter sample and no errors or issues were observed.The internal components were visualized and there were no burns or damaged parts.A device history review was performed for the finished device batch number, and no internal actions were identified.The burning smell issue reported by the customer could not be replicated during the product investigation; other issues or circumstances may have occurred during the usage of the device that compromised its performance.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.D4: udi: as the serial number for the device involved in the event was not provided, the full udi is currently not available.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).
Additional Manufacturer Narrative
During an internal review on 25-sep-2024, noted a correction to the 3500a follow-up #2 under h4.Device manufacture date as it should have been populated as 15-mar-2024.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: TX ECO CABLE
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• Manufacturer (Section G): SANMINA ISRAEL LTD.; ma¿a lot tarshiha
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 19533922
• Report Number: 2029046-2024-01939
• Device Sequence Number: 20726763
• Product Code: LPB
• UDI-Device Identifier: 10846835017427
• UDI-Public: 10846835017427
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P210027
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 10/06/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: D140102
• Device Lot Number: M2408096
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/17/2024
• Supplement Date Received by Manufacturer: 06/17/2024; 08/23/2024; 09/25/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/25/2024; 09/16/2024; 10/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2024
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CARTO 3 SYSTEM.; UNK CATHETER CABLE.; UNK_NGEN RF GENERATOR.
• Patient Sex: Unknown