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

Catalog Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Arrest (1762)

Event Date 07/11/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a right idioventicular (idvt) premature ventricular contraction(pvc) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient experienced cardiac arrest requiring medical intervention and prolonged hospitalization.It was reported by the bwi representative that after completing the idioventricular pvc ablation, the patient coded later that night and was revived.The caller stated that the procedure was uneventful and "perfect".The caller stated that they found out that the patient coded last night, but no additional information was provided.The caller stated that "they are trying to figure out the plan of care and the patient is in a therapeutic hypothermia state and alive".No ablation data is available at this time the adverse event was discovered after use of biosense webster products.The physician¿s opinion on the cause of this adverse event was the patient¿s condition since the patient has a unique condition causing the adverse event; potentially a genetic issue.The patient¿s outcome from the adverse event was reported as improved- patient is alive at this time to the best of their knowledge.Patient required extended hospitalization because of the adverse event as she was admitted prior to the procedure.

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.However, if the product or product id numbers are received at a later date, the investigation will be updated as applicable.As part of our company quality system process, all devices are manufactured, inspected, and distributed to approved specifications.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: 17442589
• MDR Text Key: 320218937
• Report Number: 2029046-2023-01670
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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: Physician
• Type of Report: Initial
• Report Date: 08/01/2023

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 Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/11/2023
• Initial Date FDA Received: 08/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SMARTABLATE GENERATOR KIT-US.; UNKNOWN DECANAV CATHETER.; UNK_CARTO VIZIGO SHEATH.; UNK_OPTRELL MAPPING CATHETER.; UNK_SOUNDSTAR.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 34 YR
• Patient Sex: Female