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

Model Number D134805

Device Problems Failure to Sense (1559); Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 11/22/2022

Event Type  Injury  

Manufacturer Narrative

The bwi product analysis lab received the device for evaluation on 08-dec-2022.The device evaluation was completed on 13-dec-2022.The product was returned to biosense webster (bwi) for evaluation.A visual inspection and an evaluation of all features of the device were performed following bwi procedures.Visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, electrical, temperature and force features were tested, the temperature and impedance values were correctly displayed, and the device was properly recognized and visualized, no electrical issues were observed either; however, error 106 was displayed due to an open circuit in the tip area.In addition, the product was deflecting and irrigating correctly.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.The force issue reported by the customer was confirmed.It should be noted that product failure is multifactorial.A force issue regarding the product was found during this investigation but based on the information available it was unrelated to the adverse event described.The root cause of the adverse event remains unknown; there may have been other circumstances or issues that occurred during the use of the device that could not be replicated during the analysis.The instructions for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.The force sensor of the catheter is disconnected.If the problem persists, replace the catheter cable or the catheter.As part of biosense webster's quality process, all devices are manufactured, inspected, and released to approved specifications.Biosense webster manufacturer's reference number (b)(4) has two complaints that are related to the same incident.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an av node ablation procedure with two thermocool® smart touch® sf bi-directional navigation catheter¿s.The patient suffered a cardiac arrest.It was reported that the carto 3 system was displaying a force sensor error 106 when the catheter was connected to the patient interface unit (piu).The cable was replaced without resolution.The catheter was replaced and the issue was resolved.The procedure was continued.It was also reported that after the procedure was completed and while the patient was on the table, the patient coded.They reported that the patient moved his left arm up and began shaking.The patient then stopped shaking and coded.Medical intervention provided was cpr and the patient came back and had a normal sinus rhythm.The patient was being admitted.The patient was reported to be in stable condition.The patient had a medtronic device and that they were unable to find any abnormalities.The physician believed that the patient coded due to respiratory issues and not due to the procedure.Multiple attempts have been made to obtain clarification to this complaint.However, no further information has been made available.With the information available the adverse event was assessed conservatively under both the thermocool® smart touch® sf bi-directional navigation catheter¿s used in the procedure.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.The force sensor error 106 was assessed as non mdr reportable.Warning functioned as intended.

• 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 ; MX
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16011662
• MDR Text Key: 305786664
• Report Number: 2029046-2022-03181
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30887222L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2022
• Initial Date Manufacturer Received: 11/22/2022
• Initial Date FDA Received: 12/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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; UNKNOWN BRAND CABLE; UNKNOWN BRAND CABLE; UNK_CARTO 3
• Patient Outcome(s): Life Threatening