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

Model Number D134805

Device Problems Signal Artifact/Noise (1036); Failure to Sense (1559)

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

Event Date 05/09/2022

Event Type  malfunction  

Event Description

It was reported that a patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was no intact ecg signal.When the catheter was plugged in at the start of the case, there was interference on the catheter channels, and on the ecg, on both carto and the ep recording system.There was no intact ecg signal.During the signal interference, the affected catheter was inside the patient¿s body.A magnetic distortion error also came up on the carto system.When the catheter was unplugged, the ecg returned to normal.The catheter cable was replaced; however, the issue was not resolved.When the catheter was replaced, the issue was resolved.No adverse patient consequence was reported.The magnetic sensor error was assessed as not mdr reportable.The issue with no ecg on all channels was assessed as a mdr reportable product malfunction.

Manufacturer Narrative

Initial reporter phone: (b)(6).This report is being submitted pursuant to the provisions of 21 cfr, part 4.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).

Manufacturer Narrative

The biosense webster, inc.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

The device evaluation was completed on 14-sep-2022.It was reported that a patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and there was no intact ecg signal.When the catheter was plugged in at the start of the case, there was interference on the catheter channels, and on the ecg, on both carto and the ep recording system.There was no intact ecg signal.During the signal interference, the affected catheter was inside the patient¿s body.A magnetic distortion error also came up on the carto system.When the catheter was unplugged, the ecg returned to normal.The catheter cable was replaced; however, the issue was not resolved.When the catheter was replaced, the issue was resolved.No adverse patient consequence was reported.Device evaluation details: the product was returned to biosense webster inc.(bwi) for evaluation.Bwi conducted a visual inspection and carto test was performed test of the returned device.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the returned device.The carto & electrical tests were performed, in accordance with bwi procedures.The returned sample was connected to the system and no error was displayed on the screen.An electrical test was performed and was found within specification.A manufacturing record evaluation was performed for the finished device 30653065l number, and no internal action related to the complaint was found during the review.It should be noted that product failure is multifactorial.The instructions for use contain the following warning stated in the carto 3 system manual: the magnetic sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The event described could not be confirmed since the catheter performed without any error.Although no product defect was identified, there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14604875
• MDR Text Key: 294539586
• Report Number: 2029046-2022-01209
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: EI
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 10/12/2022

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 Expiration Date: 11/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30653065L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/10/2022
• Initial Date FDA Received: 06/06/2022
• Supplement Dates Manufacturer Received: 08/31/2022; 09/14/2022
• Supplement Dates FDA Received: 08/31/2022; 10/12/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/17/2021
• 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: UNK BRAND CABLE; UNK BRAND CABLE; UNK BRAND CATHETER; UNK_CARTO 3