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

Model Number D134801

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

Patient Problem Pneumonia (2011)

Event Date 02/02/2023

Event Type  Death  

Event Description

It was reported that a patient underwent a paroxysmal supraventricular tachycardia ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter.The patient suffered an aggravation of interstitial pneumonia and passed away.It was reported that there was "no error during the procedure.Adverse event: death.The patient had interstitial pneumonia as a pre-existing disease, and it worsened, resulting in death.The physician's opinions on the relationship between the event and the product was that there was a possibility that the causal relationship between the adverse event and the ablation, but it is unknown if there was relationship with the jjkk products.There were no abnormalities observed prior to and during use of the product.[relevant medical history]: interstitial pneumonia.The complaint product(s) will not be returned for analysis.Additional information- the adverse event was discovered post use of biosense webster products.Physician¿s opinion on the cause of this adverse event was the patient condition.The patient had interstitial pneumonia before the procedure and he died due to aggravation of interstitial pneumonia.Outcome of the adverse event was death.Patient did not require extended hospitalization because of the adverse event as patient died.Smartablate generator was used, but the serial number was unknown.Acunav lot number qe354135 is correct lot number.In physician¿s opinion, the patient died due to aggravation of interstitial pneumonia.Physician¿s opinion on the cause of this adverse event was the patient condition.The patient had interstitial pneumonia before the procedure, and he died due to aggravation of interstitial pneumonia.Considering that the patient died 2 weeks after the procedure, there may be a causal relationship between the cause of the event and ablation.However, the relationship between the cause and the bw product was unknown.There was no problem occurred during the procedure.Other relevant history ---interstitial pneumonia.They got a report that the patient died 2 weeks after the procedure.All deaths were bwi.Fda approved ¿ ce mark devices are involved are reportable.

Manufacturer Narrative

Initial reporter phone: (b)(6).Since no device has been received for analysis, no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device number lot 30928005l and no internal action related to the complaint was found during the review.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.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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 16653559
• MDR Text Key: 312398815
• Report Number: 2029046-2023-00692
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010145
• UDI-Public: 10846835010145
• 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,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: D134801
• Device Catalogue Number: D134801
• Device Lot Number: 30928005L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/11/2022
• 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: ACUNAV CATHETER; LASSO NAV CATHETER; PENTARAY NAV; SMARTABLATE GENERATOR
• Patient Outcome(s): Life Threatening; Death; Required Intervention
• Patient Age: 79 YR
• Patient Sex: Male