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

Model Number D134805

Device Problems Complete Blockage (1094); Insufficient Cooling (1130); High Readings (2459); Contamination /Decontamination Problem (2895)

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

Event Date 06/16/2023

Event Type  malfunction  

Manufacturer Narrative

A video was received for evaluation following biosense webster's procedures.According to the video provided by the customer, a temperature alert was observed on the generator screen and the ablation was stopped.Also high impedance value was observed on the generator screen.The video did not provide sufficient information related to the occlusion issue and the foreign material reported by the customer; therefore, no results can be obtained from it.A manufacturing record evaluation was performed for the finished device lot# 30886635l, and no internal actions related to the reported complaint condition were identified.The customer complaint was confirmed from the video analysis.However, the device has not been returned for evaluation.Since no device has been received, no product investigation can be performed.If the device is received in the future, the product analysis will be performed as appropriate, in order to find the root cause of the complaint.H6.Investigation findings code of ¿appropriate term/code not available¿ represents photo/video analysis.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 a premature ventricular contraction ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter (stsf) and a foreign material on usable length of the catheter was found.It was reported that the stsf curve d/f showed a temperature alert on the smartablate system when trying to ablate.The cable was replaced but the issue did not resolve.The temperature cut-off was exceeded, and the system did not allow the ablation when the alert showed up.The generator parameters were power mode, standard.The catheter was pulled out of the patient and flushed outside; however, the solution did not go out confirming an obstruction.There was a foreign material observed but it is unknown where it came from.Everything worked fine before the catheter was inserted into the patient.When the catheter was pulled out, the biosense webster inc.(bwi) representative and the doctors observed something attached to the tip, color grey, size was almost the entire tip.The material was not loose.The doctor touched the tip and tried to remove it but was unable to.The catheter was new.There was no picture taken of the foreign material.There was no foreign material observed in the tube or solution.No material related to the incident is available to be shipped back for investigation.The surgery was delayed by about five minutes.The catheter was replaced, and the procedure was successfully completed.There was no patient consequence.The high temperature cut off exceeded (ablation stopped) issue is not mdr reportable.Since generator stopped delivering radiofrequency (rf), the most likely consequence is an intraprocedural delay.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.The high impedance issue is not mdr reportable.Since the user-defined cut-off was not exceeded, the potential that it could cause or contribute to a death, serious injury, or other significant adverse event, is remote.The occlusion/no irrigation issue is not mdr reportable.Occlusion or no irrigation is highly detectable by the physician.The potential that it could cause or contribute to a death or serious injury, or other significant adverse event, is remote.With the information available, this event was assessed as a foreign material on usable length of the catheter and is mdr reportable.

• Brand Name: THERMOCOOL® SMART TOUCH® SF BI-DIRECTIONAL NAVIGATION
• 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: 17327189
• MDR Text Key: 320046221
• Report Number: 2029046-2023-01514
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: AR
• PMA/PMN Number: P030031
• 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
• Report Date: 07/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/30/2023
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30886635L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2022
• 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: THMCL SMTCH SF BID, TC, D-F; UNK BRAND CABLE; UNK BRAND CABLE; UNK_SMARTABLATE GENERATOR
• Patient Sex: Female