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

Model Number D134701

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 11/09/2022

Event Type  Injury  

Manufacturer Narrative

The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Manufacturing record evaluation (mre) cannot be conducted because no lot number was provided by the customer.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 55-year-old male patient weighing 120.0 kgs.Underwent an afib - persistent ablation procedure with a thermocool® smart touch® sf uni-directional navigation catheter.The patient suffered a stroke.It was reported that the patient suffered a stroke after the afib ablation.This occurred four to five hours after the procedure, while the patient was in recovery.The bwi representative did not have any further information about interventions or patient status, as they were not present for the adverse event, only for the ablation procedure.They were contacted by hospital staff today with limited information.This was an octaray case.The act (activated clotting time) was over 300 for the entirety of the procedure.Bwi ablation catheter in use was the thermocool® smart touch® sf uni-directional navigation catheter.Customer requested carto 3 system evaluation and the smartablate generator evaluation.Additional information provided on 11-nov-2022.Bwi representative called back today requesting that the smartablate pump also be sent in for an evaluation due to the adverse event reported last night.They were also requesting a loaner smartablate pump.It is the physician¿s stated opinion that bwi equipment was not the cause of this adverse event.Intervention provided was unknown, adverse event occurred after the completion of the procedure, during the anesthesia recovery period.Patient required extended hospitalization because of the adverse event but details unknown.Relevant tests/laboratory data- act greater than 300 for the duration of the procedure.Other relevant history- unknown.Pump switching was appropriately switching to the correct flow rate.The octa,lng,48p,3-3-3-3-3,f-curve, lot number unknown, catheter was disposed of after procedure and prior to the adverse event; therefore, not available for analysis.

• Brand Name: THERMOCOOL® SMART TOUCH® SF UNI-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: 15946368
• MDR Text Key: 305143835
• Report Number: 2029046-2022-03064
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009774
• UDI-Public: 10846835009774
• 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: 12/08/2022

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: D134701
• Device Catalogue Number: D134701
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/09/2022
• Initial Date FDA Received: 12/08/2022
• 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: CARTO 3 SYSTEM; OCTA,LNG,48P,3-3-3-3-3,F-CURVE; SMARTABLATE GENERATOR KIT-US; SMARTABLATE PUMP KIT-US
• Patient Outcome(s): Life Threatening
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 120 KG