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

Model Number D132705

Device Problems Signal Artifact/Noise (1036); Electrical Shorting (2926); Appropriate Term/Code Not Available (3191)

Patient Problem Chest Pain (1776)

Event Date 08/25/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.(b)(4).

Event Description

It was reported that a male patient in his 20s (around (b)(6)) underwent an idiopathic ventricular tachycardia (idvt-right) premature ventricular tachycardia ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter where there were no ecg channels available to monitor the patient¿s heart rhythm to include anesthesia monitor or defibrillator.Initially, it was reported that during ablation of the right ventricular outflow tract (rvot) premature ventricular contractions (pvc), the system displayed a message stating that a current leakage has been detected.A new cable was opened; however, both catheters had the same issue.The procedure was delayed by one hour.The procedure was not successfully completed.The team ¿tried to do it conventional but it failed¿ and the team tried for ¿3 hours doing it, and at the end the patient had a chest pain¿.Additional information was received on 20-sep-2021 on the event.The physician did not have any ecg/ekg signal available to monitor the patient¿s heart rhythm to include the anesthesia monitor or defibrillator.The affected catheter was inside the patient¿s body.The current leakage error was displayed due to a signal loss.The signal interference was observed on both bs ecg and ic, as well as on both the carto and the recording system.It is unknown if the patient required extended hospitalization but the reporter thinks that the patient was discharged on the same day.In the physician¿s opinion, the procedure delay did not contribute to a serious injury to the patient.The physician's opinion on the cause of the adverse event is that it is product malfunction related.Since the physician did not have any ecg channels available to monitor the patient¿s heart rhythm to include anesthesia monitor or defibrillator, this event has been reassessed to a reportable malfunction.The awareness date for this issue is 20-sep-2021.The adverse event of chest pain was assessed as not mdr reportable.It was not life threatening; did not result in permanent impairment of a body function or permanent damage to a body structure; or did not necessitate medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure.The potential risk that it could cause or contribute to a serious injury or death to the operator or patient was remote.The current leakage error was assessed as not mdr reportable.This issue was highly detectable and requires adjusting the system components to continue with the procedure.Devices may require reset or replacing but cannot be used on the patient.Patient safety was unaffected by this issue.

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 (mre) was performed for the finished device 30494556m number, and no internal action related to the complaint was found during the review.Based on the mre, d4.Expiration date and h4.Device manufacture date have been updated.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: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 12635886
• MDR Text Key: 281436653
• Report Number: 2029046-2021-01757
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009200
• UDI-Public: 10846835009200
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: P030031/S053
• 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
• Report Date: 01/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/27/2022
• Device Model Number: D132705
• Device Catalogue Number: D132705
• Device Lot Number: 30494556M
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/28/2021
• 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: PENTARAY NAV ECO 7FR, D, 4-4-4; UNKNOWN BRAND 4MM CATHETER; UNKNOWN BRAND CABLE; UNK_SMARTABLATE GENERATOR
• Patient Sex: Male