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 Vascular Dissection (3160)

Event Date 02/04/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: the device has been reported as discarded, 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.Manufacturer's ref.# (b)(4).

Event Description

It was reported that a patient underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered aortic dissection.It was reported that a thermocool getouch® sf catheter had a catheter sensor error (error#105) displayed on the carto® 3 system.The cable was replaced without resolution.The catheter was replaced, and the issue was resolved.The case continued.The issue was reported as catheter-related and the carto® 3 system was operating per specs.The customer¿s reported sensor error (#105) is not an mdr reportable event since the incidence of magnetic sensor error is easy detectable by the user.The catheter is inoperable since it cannot be visualized on the carto system.The user will have to replace the catheter.The most likely consequence is an intraprocedural delay and the potential risk that it could cause or contribute to a serious injury or death is remote.It was also reported that during the exchange of the catheters there is a possibility that an aorta dissection may have occurred.The caller stated that after the catheter exchange the physician could not get back to the same area they were before.The case was stopped, and a computed tomography (ct)-scan was conducted.The results showed an aorta dissection, and the physician could not determine when this happened.The patient was in stable condition.This adverse event was discovered post use of biosense webster products.The physician¿s opinion was that patient condition was the cause of the adverse event.No intervention was required, and the patient has fully recovered.Extended hospitalization because of the adverse event was not required.A transseptal puncture was not performed and no ablation was performed.The irrigation was set to low flow.The correct catheter settings were selected on the generator.

• 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: 13659315
• MDR Text Key: 288999296
• Report Number: 2029046-2022-00440
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010183
• UDI-Public: 10846835010183
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/03/2022

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 Model Number: D134805
• Device Catalogue Number: D134805
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 03/03/2022
• 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; THMCL SMTCH SF BID, TC, D-F; UNKNOWN GENERATOR; UNKNOWN PUMP; UNSPECIFIED CABLE
• Patient Outcome(s): Other