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

Model Number D134805

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Stenosis (2263)

Event Date 10/07/2022

Event Type  Injury  

Manufacturer Narrative

Device investigation details: 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.A manufacturing record evaluation was performed for the finished device number lot 30837246l and no internal actions 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.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 ref.# (b)(4).

Event Description

It was reported that a 66-year-old male patient, weighing 75 kgs, underwent a cardiac ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and the patient suffered coronary artery stenosis requiring a percutaneous coronary intervention (pci).It was reported coronary artery stenosis occurred immediately after ablation.Pci was performed and the procedure was terminated when the patient's condition was recovered.Although blood pressure temporarily decreased, the patient recovered with medication and pci.There is no particular problem now.The physician's opinions on the relationship between the event and the product: the indirect spread of heat after the ablation may be a factor rather than direct damage due to ablation.There were no abnormalities observed prior to or during use of the product.Additional information received indicating the patient outcome from the adverse event is fully recovered.

Manufacturer Narrative

On 27-dec-2022, additional information was received indicating the patient did not required extended hospital stay.There was no other relevant medical history.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's ref.# (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: kate karberg ; 31 technology dr; irvine, CA 92618 ; 3035526892
• MDR Report Key: 15726652
• MDR Text Key: 303058996
• Report Number: 2029046-2022-02723
• 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,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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 Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30837246L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/07/2022
• Initial Date FDA Received: 11/04/2022
• Supplement Dates Manufacturer Received: 12/27/2022
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: 7FR DECAN,11P,D,2.4MMLE,282MM,; JPN CARTO 3 SYSTEM; SOUNDSTAR ECO SMS 8F CATHETER; UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 75 KG