MAUDE Adverse Event Report: BIOSENSE WEBSTER INC THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER; SIMILAR DEVICE D132701, PMA # P030031/S053

Catalog Number UNK_SMART TOUCH BIDIRECTIONAL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Insufficient Information (4580)

Event Date 10/07/2022

Event Type  Death  

Event Description

It was reported that a patient underwent an ablation procedure with a thermocool® smart touch¿ bi-directional navigation catheter and after the procedure was completed, the patient expired.Initially it was reported that a 106-error occurred when the catheter was connected.The issue was resolved by changing the thermocool® smart touch® sf bi-directional navigation catheter to another one.The procedure was completed without patient's consequence.The force sensor error 106 was assessed as not mdr reportable.The warning functioned as intended.Additional information was received on 17-oct-2022.Patient death was reported on (b)(6)2022.The physician's opinion on the relationship between the event and the products is that there is not a relationship with the product because the patient's individual condition was originally bad.No abnormalities were observed prior to use or during use of the product.Additional information was received on 20-oct-2022.The patient passed away between 07-oct-2022 and 17-oct-2022 after the ablation procedure completed.The exact date of the patient's death is unknown and additional specifics could not be obtained because of regulations regarding patient's personal information.Physician¿s opinion is cause of death is related to patient¿s condition and not the bwi product.The force visualization features used were real time graph; dashboard; vector; visitag.Additionally, the fot filter and force-tag index were also utilized in the case.The death adverse event was assessed as mdr reportable under the exchanged catheter used in the procedure.Additional attempts have been made to obtain the product information of the second catheter used.However, no further information has been made available.Therefore, we are conservatively reporting this event under the thermocool® smart touch¿ bi-directional navigation catheter.The awareness date of this reportable adverse event was (b)(6) 2022.

Manufacturer Narrative

Initial reporter phone: (b)(6).Since the date of death is not known; however, it was stated that it occurred between 07-oct-2022 to 17-oct-2022 after the ablation procedure was completed.Therefore, using the earliest date of (b)(6) 2022 to update the date of death field.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.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.Manufacturer's reference number: (b)(4).

• Brand Name: THERMOCOOL® SMART TOUCH¿ BI-DIRECTIONAL NAVIGATION CATHETER
• Type of Device: SIMILAR DEVICE D132701, PMA # P030031/S053
• 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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15789425
• MDR Text Key: 303574516
• Report Number: 2029046-2022-02824
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P030031/S053
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/14/2022

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_SMART TOUCH BIDIRECTIONAL
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/17/2022
• Initial Date FDA Received: 11/14/2022
• 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: THMCL SMTCH SF BID, TC, D-F.; UNK_CARTO 3.
• Patient Outcome(s): Death