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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 11/08/2022

Event Type  Injury  

Manufacturer Narrative

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.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.Patient was wheeled into the laboratory at 09:00, groin puncture was around 09:30.At the beginning of the pulmonary vein isolation (pvi) procedure, transeptal puncture (tsp) was performed and a pentaray catheter and a thermocool® smart touch® sf bi-directional navigation catheter were advanced into the left superior pulmonary vein (lspv) in the left atrium (la) via a fixed sl0 sheath.Around 10:15 am, the thermocool® smart touch® sf bi-directional navigation catheter displayed the error "106, sensor error".Replacing the cable did not resolve the error; only after replacing the thermocool® smart touch® sf bi-directional navigation catheter with another thermocool® smart touch® sf bi-directional navigation catheter could the procedure continue.Around 10:40 a.M., the patient's systolic blood pressure dropped from 100 mmhg to below 70 mmhg, and a cardiac ultrasound performed and confirmed the suspicion of a pericardial effusion.At 10:55 am, the pericardium was successfully punctured on the first attempt and a total of 970ml of blood was drawn from the pericardium.At 11:15 am the sheaths and catheters were removed from the groin and at 12:35 pm the patient could be transferred to the intensive care unit (icu) in stable condition.The procedure was not completed due to the pericardial effusion.The fluorine duration was 12.5 min, and the fluorine dose was 283.77 ugym2.Presumably, perforation of the cardiac wall occurred in the lspv ostium region.Parameters for stability for the visitag module used was 3mm/3mm.Filter used with the visitag were only those recommended by biosense webster.A brk-1 71cm needle, reprocessed by vanguard, was used for the transseptal puncture performed.Flow setting for the irrigated catheter was as recommended by biosense webster.

Manufacturer Narrative

On 14-dec-2022, the bwi product analysis lab received the complaint device for evaluation.The product analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (b)(4).

Manufacturer Narrative

It was reported that a patient underwent an unknown ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered cardiac tamponade requiring pericardiocentesis.Patient was wheeled into the laboratory at 09:00, groin puncture was around 09:30.At the beginning of the pulmonary vein isolation (pvi) procedure, transeptal puncture (tsp) was performed and a pentaray catheter and a thermocool® smart touch® sf bi-directional navigation catheter were advanced into the left superior pulmonary vein (lspv) in the left atrium (la) via a fixed sl0 sheath.Around 10:15 am, the thermocool® smart touch® sf bi-directional navigation catheter displayed the error "106, sensor error".Replacing the cable did not resolve the error; only after replacing the thermocool® smart touch® sf bi-directional navigation catheter with another thermocool® smart touch® sf bi-directional navigation catheter could the procedure continue.Around 10:40 a.M., the patient's systolic blood pressure dropped from 100 mmhg to below 70 mmhg, and a cardiac ultrasound performed and confirmed the suspicion of a pericardial effusion.At 10:55 am, the pericardium was successfully punctured on the first attempt and a total of 970ml of blood was drawn from the pericardium.At 11:15 am the sheaths and catheters were removed from the groin and at 12:35 pm the patient could be transferred to the intensive care unit (icu) in stable condition.The procedure was not completed due to the pericardial effusion.Device evaluation details: the product was returned to biosense webster inc (bwi) for evaluation and the evaluation has been completed.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 and no issues were observed.In addition, the product was deflecting and irrigating correctly.No malfunctions were observed during the product analysis.A manufacturing record evaluation was performed for the finished device batch number, and no internal actions were identified.No malfunction was observed during the product analysis.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 instruction for use (ifu) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.The root cause of the adverse event remains unknown.As part of biosense webster¿s quality process, all devices are manufactured, inspected, and released 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: 15939374
• MDR Text Key: 305056344
• Report Number: 2029046-2022-03056
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• 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,Followup,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• 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: 30875382L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: No
• 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: ACUNAV 8F-90; BRK-1 71CM NEEDLE REPROCESSED BY VANGUARD; CARTO 3 SYSTEM; PENTARAY NAV ECO 7FR, F, 2-6-2; SL0 SHEATH; SMARTABLATE GENERATOR KIT-WW; THMCL SMTCH SF BID, TC, D-F; UNKNOWN PUMP
• Patient Outcome(s): Life Threatening; Required Intervention