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

Catalog Number D134702

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 01/01/2023

Event Type  Injury  

Event Description

It was reported that a patient underwent a cardiac ablation procedure that included thermocool® smart touch® sf uni-directional navigation catheter and the patient experienced decreased blood pressure that required transfer to the intensive care unit.It was reported that during ablation with bwi products, a steam pop occurred at the ridge between the left appendage and the left superior pulmonary vein (lspv).The procedure could be performed until pulmonary vein isolation (pvi) was reached.Blood pressure dropped after the procedure requiring a cardiac echo.No pericardial tamponade was noted.The patient was transferred to the intensive care unit for safety reasons.The surgery was not delayed due to the reported event.The procedure was successfully completed.No other interventions are known.This issue occurred towards the end of the procedure (one of the last five or ten ablation points).The smartablate generator was used in power control mode.Thresholds unknown.No error reported by biosense webster systems.Parameters for stability used were range: 3mm, time: 3s.Additional filter used with visitag was force over time (fot) of 25% and 3g.Color options used was tag index (specific coloring thresholds unknown).

Manufacturer Narrative

Device investigation details: information received indicates that the device is not available for return, 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.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.The date of event was not provided.As such, field b3.Date of event has been populated with (b)(6) 2023.E1.Initial reporter phone: (b)(6).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 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 32599 ; MX 32599
• Manufacturer Contact: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 17553425
• MDR Text Key: 321225949
• Report Number: 2029046-2023-01784
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835009781
• UDI-Public: 10846835009781
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/15/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134702
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/20/2023
• 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: CARTO 3 SYSTEM; SMARTABLATE GENERATOR KIT-WW
• Patient Outcome(s): Hospitalization