MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D132705

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

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

Event Date 12/08/2022

Event Type  malfunction  

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.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 an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.There was signal loss with no ecg (electrocardiogram) available to monitor patient.Current leakage error that resolved by swapping the catheter, faulty when opened.The "current leakage error" was accompanied by a signal noise.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto and the recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.No patient consequences were reported.Current leakage is not mdr-reportable.Bad/no ecg on all channels (bs and ic) is mdr-reportable.

Manufacturer Narrative

On 10-jan-2023, the bwi product analysis lab received the device for evaluation.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).

Manufacturer Narrative

On 9-mar-2023, the product investigation was completed.It was reported that an unknown patient underwent an unknown ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter.There was signal loss with no ecg (electrocardiogram) available to monitor patient.Current leakage error that resolved by swapping the catheter, faulty when opened.The "current leakage error" was accompanied by a signal noise.The signal interference (noise/loss) was observed on all ecg (bs + ic) channels.The signal interference (noise/loss) was observed on carto and the recording system.There was no ecg/ekg signal available for the physician to monitor the patient¿s heart rhythm.During the signal interference/loss, the affected catheter was inside the patient¿s body.No patient consequences were reported.Device evaluation details: visual analysis revealed corrosion in the connector area.A magnetic test was performed, and no errors were observed.An electrical test was performed, and no electrical issues were found.As additional tests the device was tested in an irrigation test and no water leakage was observed.The device was dissected and no corrosion was found inside.The corrosion could be related to the electrical issue reported by the customer; other issues or circumstances may have occurred during the usage of the device that compromised its performance.A manufacturing record evaluation was performed for the finished device (b)(6) number, and no internal actions related to the reported complaint condition were identified.  as part of biosense webster¿s quality process, all devices are manufactured, inspected, and released to approved specifications.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: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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: 16098532
• MDR Text Key: 308643676
• Report Number: 2029046-2023-00022
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: P030031/S053
• 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,Followup
• Report Date: 04/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30868520M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/25/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: CARTO 3 SYSTEM