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

Model Number D134805

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

Patient Problem Insufficient Information (4580)

Event Date 03/08/2022

Event Type  Death  

Event Description

It was reported that a male patient underwent an atrioventricular reentrant tachycardia (avrt)/ wolff-parkinson-white (wpw) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient died two days after ablation.A pulmonary vein isolation (pvi) and / wolff-parkinson-white (wpw) procedure was performed and there was no particular change after the procedure; however, the patient died 2 days later.No particular event was noted in the procedure.No problem was noted immediately after the case, and death was confirmed 2 days later.It is highly likely that an autopsy will be performed in the future.The physician commented that no particular change was noted in the procedure and the procedure was treated as usual.The physician did not provide a causality opinion for the cause of this adverse event.Additional information was received on the event.The date of death was (b)(6) 2022.There were no bwi product malfunctions or adverse event occurred during the initial procedure.A smart ablate generator was used in the event.

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.Investigation is in progress, once completed a supplemental will be submitted.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.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).

Manufacturer Narrative

Additional information was received on 19-apr-2022.The patient is 54 years old.Therefore, processed fields a2.Patient age at the time of event and a2.Age unit.Originally the date of death was reported as (b)(6) 2022.The additional information updated the date of death to (b)(6) 2022.Therefore, updated field b2.Date of death.The physician information was provided.Therefore, updated section e.Initial reporter.The device evaluation was completed on 28-apr-2022.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 was performed for the finished device number 30661583l and no internal actions related to the complaint was found during the review.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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 14097940
• MDR Text Key: 289167222
• Report Number: 2029046-2022-00787
• 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: Physician
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

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: 11/28/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30661583L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 04/13/2022
• Supplement Dates Manufacturer Received: 04/19/2022
• Supplement Dates FDA Received: 05/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/29/2021
• 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: LASSO NAV 2515,22P SPLITHANDLE.; PENTARAY NAV ECO 7FR, D, 2-6-2.; SOUNDSTAR ECO SMS 8F CATHETER.; UNK_SMARTABLATE GENERATOR.
• Patient Outcome(s): Death
• Patient Age: 54 YR
• Patient Sex: Male