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

Model Number D134805

Device Problem Communication or Transmission Problem (2896)

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

Event Date 05/04/2023

Event Type  malfunction  

Manufacturer Narrative

Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30966035l and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm issue occurred.When the thermocool® smart touch® sf bi-directional navigation catheter was plugged all ekg and intracardiac (ic) signals disappeared.Changing the cable did not solve the issue.Changing the thermocool® smart touch® sf bi-directional navigation catheter solved the issue.There was no patient consequence reported.Additional information was received on 16-may-2023.The signal interference was observed on all ecg channels.The signal interference was observed on both the carto and the recording system.The physician did not have any intact ecg signal available to monitor the patients heart rhythm.The physician had no other way of monitoring the patient¿s heart rhythm.The affected catheter was inside the patient¿s body.This event was originally considered non-reportable, however, bwi became aware that the physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm on (b)(6) 2023 and have reassessed the event as reportable.

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 24-jun-2023.The device evaluation was completed on 06-jul-2023.It was reported that a patient underwent an ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the physician did not have any intact ecg signal available to monitor the patient¿s heart rhythm issue occurred.The device was returned to biosense webster (bwi) for evaluation.Visual inspection and electrical test of the returned device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.An electrical test was performed, and no electrical issues were found.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The electrical 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.The instructions for use contain the following recommendation: ecg noise is typically generated as the result of the improper connection of the body surface ecg patch to the patient.This noise is the most significant during ablation.To resolve this situation, verify the proper connection.It is recommended to turn off the notch filter for this verification.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® SF 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: 17101045
• MDR Text Key: 317723755
• Report Number: 2029046-2023-01263
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: P030031
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30966035L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/24/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/05/2023
• 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: UNKNOWN BRAND CABLE.; UNKNOWN BRAND CABLE.; UNKNOWN BRAND CATHETER.; UNKNOWN BRAND RECORDING SYSTEM.; UNK_CARTO 3.