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 Thrombosis/Thrombus (4440)

Event Date 04/29/2021

Event Type  Injury  

Manufacturer Narrative

Since no device has been received for analysis, 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.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a thrombus requiring medical intervention.During the procedure, a large clot was discovered on the transseptal sheath.It was reported that the clot was not present before the case and it was not confirmed what caused the clot.The thrombus/clot was confirmed on intracardiac echocardiography (ice).Medical intervention was provided by a cardiologist that was brought in after they discovered the clot.The cardiologist attempted to use a filter catheter to try to catch the thrombus but was unsuccessful because they could no longer see the thrombus on ice.When the filter was pulled out, they could not see the thrombus in the filter either so they believed that it may have gotten loose in the patient's skin on the way out.The procedure was canceled and was not able to be completed.However, the caller confirmed that the cavo-tricuspid isthmus (cti) line was done at the beginning of the procedure before they began to set up to go transseptal, so they were able to complete some ablation.No adverse patient consequences were reported.Additional information was received, and it was reported that the event was discovered mid-procedure.The biosense webster inc.(bwi) coronary sinus (cs) catheter was in place.The physician administered heparin.The information regarding activated clotting time (act) was not available at the time the complaint was reported.The physician does not believe that the bwi product contributed to the adverse event.He is unsure why the patient developed the thrombus.The patient has since fully recovered.The patient was discharged the following day, on (b)(6) 2021, from the hospital.No further information is available regarding the patient.There were no error messages on the system and there were no issues related to temperature or flow rate.The generator parameters, temperature, impedance or power for the ablations done on the cti are unknown.The correct settings were selected for the irrigation catheter.It switched from low to high flow during ablation.Ablation duration was less than 60 seconds.Average contact force was less than 40 grams.Irrigation rate was standard prescribed settings.Pre ablation high settings was 2 seconds.Heparinized normal saline was used as the irrigation fluid.Visitag was used with the following settings: 2 mm; 3 s; 25% at 3 grams, respiratory on, 3 mm tags; colored by surpoint tag index.A smartablate irrigation pump was used.Since the event (thrombus) is life threatening and required intervention to prevent permanent impairment of a body function or permanent damage to a body structure, then it is to be considered serious and mdr-reportable.

Manufacturer Narrative

The biosense webster inc product analysis lab received the device for evaluation on 28-jul-2021.The device evaluation was completed on 30-jul-2021.It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and suffered a thrombus requiring medical intervention.During the procedure, a large clot was discovered on the transseptal sheath.It was reported that the clot was not present before the case and it was not confirmed what caused the clot.The thrombus/clot was confirmed on intracardiac echocardiography (ice).Medical intervention was provided by a cardiologist that was brought in after they discovered the clot.The cardiologist attempted to use a filter catheter to try to catch the thrombus but was unsuccessful because they could no longer see the thrombus on ice.When the filter was pulled out, they could not see the thrombus in the filter either so they believed that it may have gotten loose in the patient's skin on the way out.The procedure was canceled and was not able to be completed.However, the caller confirmed that the cavo-tricuspid isthmus (cti) line was done at the beginning of the procedure before they began to set up to go transseptal, so they were able to complete some ablation.No adverse patient consequences were reported.Visual analysis of the returned sample revealed that no damage or anomalies were observed on the thermocool® smart touch® sf bi-directional navigation catheter.Per the event, several tests were performed.The force, magnetic and temperature 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 (mre) was performed for the finished device 30531301m number, and no internal action related to the complaint was found during the review.Based on the completed mre, the d4.Lot, d4.Expiration date and h4.Device manufacture date have been updated.As part of bwi¿s quality process all catheters are manufactured, inspected, and released to approved specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation, or tamponade.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (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
• MDR Report Key: 11899355
• MDR Text Key: 257153255
• Report Number: 2029046-2021-00850
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30531301M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 07/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN BRAND GENERATOR.; UNKNOWN BRAND TRANSSEPTAL SHEATH.; UNKNOWN FILTER CATHETER.; UNK_CARTO 3.; UNK_CORONARY SINUS CATHETER.; UNK_SMARTABLATE PUMP.
• Patient Outcome(s): Life Threatening; Required Intervention