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 Problems Vasoconstriction (2126); Stenosis (2263); Ischemic Heart Disease (2493)

Event Date 04/14/2022

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).Initial reporter address line 1(cont.): (b)(6).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 30694252l and no internal action related to the complaint was found during the review.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient underwent a cavotricuspid isthmus (cti) ablation procedure with a thermocool® smart touch® sf bi-directional navigation catheter and experienced coronary spasm and st segment elevation requiring coronary angiography.After cti ablation was conducted, antitachycardia pacing (atp) and isupril (isp) were applied at load.Then ventricular tachycardia (vt) was induced, 12 lead ecg was confirmed, st elevation was observed in ii, iii, and avf.Coronary angiography (cag) was performed, and stenosis of coronary artery # 3 was confirmed.The symptom was improved with the nitroglycerin administration.This occurred after isp was applied load.The coronary spasm occurred at the time of cti ablation.The symptoms improved with the nitroglycerin during the procedure.St elevation was also improved.The patient outcome of the adverse event was reported as improved.There was no comment from the physician about the relationship between the event and the biosense webster (bwi) product.The generator used in the case was a smartablate generator with serial number unknown.

• 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: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14379583
• MDR Text Key: 291837374
• Report Number: 2029046-2022-01014
• 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
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/12/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 12/16/2022
• Device Model Number: D134805
• Device Catalogue Number: D134805
• Device Lot Number: 30694252L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/14/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/17/2021
• 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: UNK_SMARTABLATE GENERATOR
• Patient Outcome(s): Required Intervention
• Patient Sex: Female