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

Catalog Number UNK_SMRTTOUCH BIDIRECTNL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Thrombosis/Thrombus (4440)

Event Date 10/13/2021

Event Type  Injury  

Manufacturer Narrative

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 a ventricular tachycardia/ premature ventricular contraction (vt/pvc) ablation procedure with an unknown thermocool® smart touch® sf bi-directional navigation catheter and suffered a thrombosis.The biosense webster, inc.(bwi) representative was alerted to this event during a symposium in oslo.Electrophysiology (ep) made the representative aware of a procedure outcome.It was reported that an emboli in one eye was seen in the patient two weeks after the procedure.The patient consequence was described as having blood clot in the eye.With the information available, this was conservatively assessed as a mdr reportable patient event of thrombosis.If additional information is made available, it will be evaluated accordingly.

Manufacturer Narrative

Additional information was received on 13-dec-2021.It was reported that the date of event is (b)(6) 2021.Therefore, b 3.Date of event has been updated.It was also reported that the patient is a 50-year-old female.Therefore, a 2.Patient age at the time of event, a2.Age unit, and a 3.Gender have been updated.The physician name and contact information were provided.Therefore, the e 1.Initial reporter title, e1.Initial reporter first name, e 1.Initial reporter last name, e1.Initial reporter facility name, e 1.Initial reporter address line 1, e1.Initial reporter email were updated.The adverse event was discovered post use of biosense webster products (2 weeks after).The physician¿s opinion on the cause of this adverse event is that it is procedure related.A cerebral mri was performed.The patient outcome of the adverse event is partial blindness on right eye and was also reported as improved.The patient did not require extended hospitalization because of the adverse event.Generator information provided was smartablate, g4c-2908.Therefore, the concomitant product section was updated.The ablation catheter used in the case was a thermocool® smarttouch® sf, lot n/a.Visitag module parameters for stability were 3 mm, 3 sec with no additional filter.The medical safety officer (mso) reviewed this event on 16-dec-2021 and it was determined that this is a cerebrovascular accident.Therefore, the h6.Health effect - clinical code has been updated with the code of stroke/cva (e0133).Additional information received indicates that the device is not available for return, therefore 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).

• 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: 12958372
• MDR Text Key: 281908605
• Report Number: 2029046-2021-02130
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: IC
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/05/2022

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 Catalogue Number: UNK_SMRTTOUCH BIDIRECTNL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/11/2021
• Initial Date FDA Received: 12/08/2021
• Supplement Dates Manufacturer Received: 12/13/2021
• Supplement Dates FDA Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: 7FR DECAN,11P,F,2.4MMLE,282MM,.; SMARTABLATE GENERATOR KIT-WW.
• Patient Outcome(s): Life Threatening
• Patient Age: 50 YR
• Patient Sex: Female