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 Problems Cardiac Arrest (1762); Tachycardia (2095)

Event Date 02/25/2022

Event Type  Injury  

Event Description

It was reported that an unknown male patient underwent a ventricular tachycardia.(vt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered cardiac arrest requiring resuscitation, surgical intervention, and prolonged hospitalization.It was reported that since the origin of vt was inferred to be epicardium (epi) by the surface electrocardiogram (ecg), ablation was performed by epicardium approach.Although coronary angiogram (cag) was performed, there was a tendency toward spasm overall, and blood pressure was low, 70 mmhg from the time of admission.The patients¿ blood pressure sometimes dropped to 30 mmhg without using a vasopressor, therefore blood pressure was maintained with a vasopressor.A sheath was introduced into the epi, and map was performed using the decanav, and an anomalous electrical potential was found below the right coronary artery (rca).When it was looked at the isochronal, the color was blocked, so ablation was conducted with stsf on the surface.The output was 30 w, the ai was aimed at 500, and the cf was approximately 10 g or less during ablation.During ablation, blood pressure decreased to 20 mmhg and vt occurred.Cardiac arrest occurred thereafter.Defibrillation (dc) was performed from the body surface, but vt did not stop.It was unknown whether it was pacing rhythm from the icd or not, so dc was performed, but as a result, the pulse disappeared, and resuscitative measures were taken.This occurred about 30 minutes since the stsf was used.An intra-aortic balloon pump (iabp) and percutaneous cardiopulmonary support (pcps) were inserted, and the patient left the room.Contact force was monitored by dashboard, vector, and visitag.Color setting of visitag was tag index.Additional filter was fot.The physician commented that it was not related to product.The patient¿s medical history: icd had been inserted and vt had often been seen at the ward but vt was not stopped by icd.Therefore, ablation was performed for the vt.The physician¿s opinion on the cause of this adverse event is that it is not related with the bwi product malfunction.The patient outcome of the adverse event improved.The patient did require extended hospitalization because of the adverse event, details are unknown.Other relevant history includes icd, and vt that occurred frequently in the ward.However, it did not stop with icd and decided to conduct ablation.A smartablate generator was used, no serving is needed for it.Since the event is life threatening and it might result in permanent impairment of a body function or permanent damage to a body structure; or it could require medical or surgical intervention to prevent permanent impairment of a body function or permanent damage to a body structure, it is to be considered serious and mdr-reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).The bwi product analysis lab received the device for evaluation.The 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 reference number: (b)(4).

Manufacturer Narrative

On 4-apr-2022, bwi received additional information regarding the event.It was reported that a 74-year-old male patient (66kg) underwent a ventricular tachycardia.The physician¿s opinion on the cause of this adverse event was not related with the bwi product malfunction.The patient outcome of the adverse event improved.The patient did require extended hospitalization because of the adverse event.There was an icd, and vt occurred frequently in the ward.However, it did not stop with icd and decided to conduct abl.The generator was a smartablate and it does not need service.Additionally, the product investigation was completed on 21-apr-2022.Device evaluation details: visual analysis revealed no damage or anomalies on the device.Per the event, several tests were performed.The magnetic, 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 30694181l number, and no internal action was found during the review.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 ifu (instruction for use) states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.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.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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13837760
• MDR Text Key: 290783899
• Report Number: 2029046-2022-00584
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/26/2022

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 Expiration Date: 12/09/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30694181L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/16/2022
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/25/2022
• Initial Date FDA Received: 03/21/2022
• Supplement Dates Manufacturer Received: 04/04/2022
• Supplement Dates FDA Received: 04/26/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2021
• 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.; DECANAV CATHETER.; SMARTABLATE GENERATOR.; SOUNDSTAR ECO CATHETER.; VISITAG MODULE.
• Patient Outcome(s): Life Threatening; Hospitalization; Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 66 KG