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 Stenosis (2263)

Event Date 01/31/2023

Event Type  Injury  

Manufacturer Narrative

On 27-feb-2023, 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.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.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).

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 the patient suffered coronary artery stenosis.It was also reported that during pulmonary vein isolation (pvi), transient st elevation was confirmed on the electrocardiogram.It occurred after ablation of the left pulmonary vein (lpv).Ablation had been conducted about 70 points at this time.St elevation itself occurred when the ablation was not conducted.About two hours and 40 minutes had been passed since the patient entered the room.During left atrial access, activated clotting time (act) was controlled at 300 sec with heparin, and act measured immediately before the event was 333 sec.The event was resolved spontaneously within a few minutes.The ablation was interrupted once, and emergency coronary angiography (cag) was performed.The findings were due to coronary spasm reaction and a judgment that stenosis was observed in part of the left anterior descending artery (lad), leading to ischemia in some way.All ablation status on carto 3 system was confirmed, but no abnormal value was found in contact force (cf) or impedance trend.The procedure was resumed at the physician's discretion, and cag was performed again after completion of the ablation.Because there was a similar stenosis, percutaneous cornary intervention (pci) was considered later.The procedure had been completed without any other major problems.All catheters used were confirmed, but no adhesion of thrombus was found.The event was transient, and the st level returned to the level at the time of entering the room when the patient left the room.The patient returned to the general ward without additional monitoring.It depends on whether coronary artery treatment is performed or not, but there has been no talk of extension of hospitalization at this point.The physician's opinions on the relationship between the event and the product was that the event was caused by coronary spasm response and functional stenosis, and the possibility of thrombus caused by the ablation was low and then the physician reported thrombus due to ablation treatment was unlikely.There were no abnormalities observed prior to and during use of the product.No surgical intervention provided.The patient¿s outcome from the adverse event was reported as fully recovered.The symptoms disappeared when the patient left the catheter room.No extended hospitalization required.According to the physician, the patient was discharged from the hospital as scheduled without any additional treatment.In addition, it was reported that there were bubbles observed throughout the tube at the time of priming.Bubble movement was absent while the pump was operating, error was absent at the pump.Flush was performed, but the issue was not improved.Improved by replacing of the tubing set with another lot number.The customer¿s reported bubble issue is not considered to be mdr reportable since bubbles that cannot be flushed would lead to procedural delay/customer annoyance since the user will need to change the tubing prior to continuing the procedure.The risk to the patient is remote.

Manufacturer Narrative

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered coronary artery stenosis.It was also reported that during pulmonary vein isolation (pvi), transient st elevation was confirmed on the electrocardiogram.It occurred after ablation of the left pulmonary vein (lpv).Ablation had been conducted about 70 points at this time.St elevation itself occurred when the ablation was not conducted.About two hours and 40 minutes had been passed since the patient entered the room.During left atrial access, activated clotting time (act) was controlled at = 300 sec with heparin, and act measured immediately before the event was 333 sec.The event was resolved spontaneously within a few minutes.The ablation was interrupted once, and emergency coronary angiography (cag) was performed.The findings were due to coronary spasm reaction and a judgment that stenosis was observed in part of the left anterior descending artery (lad), leading to ischemia in some way.All ablation status on carto 3 system was confirmed, but no abnormal value was found in contact force (cf) or impedance trend.The procedure was resumed at the physician's discretion, and cag was performed again after completion of the ablation.Because there was a similar stenosis, percutaneous cornary intervention (pci) was considered later.The procedure had been completed without any other major problems.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.The physician's opinions on the relationship between the event and the product (comments): the event was caused by coronary spasm response and functional stenosis, and the possibility of thrombus caused by the ablation was low.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.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: 16449138
• MDR Text Key: 310321339
• Report Number: 2029046-2023-00394
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/21/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2023
• 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: 30922922L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/01/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/19/2022
• 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: 7FR DEF LASSONAV SH,12P,15MM,D; 7FR DEF LASSONAV SH,12P,20MM,D; CARTO 3 SYSTEM; SMARTABLATE GEN. KIT (JAPAN); SMARTABLATE IRR TUBE SET
• Patient Outcome(s): Other
• Patient Sex: Female