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

Catalog Number D134801

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stroke/CVA (1770)

Event Date 12/07/2021

Event Type  Injury  

Manufacturer Narrative

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 reference number: (b)(4).

Event Description

It was reported that a patient underwent an atrial fibrillation (afib) ablation procedure with an unknown thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered a cerebrovascular accident (cva) requiring prolonged hospitalization.The patient was treated for afib.Cerebral infarction was found at a later date.During the procedure, no scenes that particularly large changes in impedance or higher abnormally contact force.There were no abnormalities in the carto 3-related equipment or consumables.However, there was a scene where spo2 decreased to 10% after the procedure, which it was likely the cause, but the details were unknown.Because transesophageal echocardiography was not performed at the facility, the presence or absence of thrombus before the procedure was unknown.The cva was diagnosed 3 days after the day of the procedure.The patient has been probably hospitalized.There was comment no particular from the physician.No abnormalities were observed before or during use of the product.

Manufacturer Narrative

Additional information was received on 20-jan-2022.The physician¿s opinion on the cause of this adverse event was there was a scene where spo2 dropped to 10% after the case, which is likely to be the cause.Patient outcome of the adverse event is that the patient seems to be in the hospital.Additional concomitant products were provided.Therefore, updated d10.Concomitant medical products and therapy dates field.Initially the device reported was an unknown thermocool® smart touch® sf bi-directional navigation catheter.Additional information provided the device catalog number.Therefore, updated d4.Catalog, d4.Unique identifier( udi) and g4.Pma/ 510(k).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 ; MX
• Manufacturer Contact: gabriel alfageme ; 31 technology dr; irvine, CA 92618 ; 9497898687
• MDR Report Key: 13122474
• MDR Text Key: 285561801
• Report Number: 2029046-2021-02280
• Device Sequence Number: 1
• Product Code: LPB
• 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: 02/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: D134801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: No
• 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 (FOR JAPAN); LASSO NAV 2515,22P SPLITHANDLE; PENTARAY NAV ECO 7FR, D, 2-6-2; PREF GUIDING SHEATH:MULTI-SHRT; SOUNDSTAR ECO SMS 8F CATHETER
• Patient Outcome(s): Hospitalization; Life Threatening