MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER; ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION

Model Number BN7TCDF4L

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stenosis (2263); Ischemic Heart Disease (2493); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 08/03/2022

Event Type  Injury  

Event Description

It was reported that a pediatric male patient (43kg) born on (b)(6) 2007 with a history of idiopathic vt and pvc¿s underwent an idiopathic ventricular tachycardia (idvt) ablation procedure with a ez steer¿ nav bi-directional electrophysiology catheter and suffered a thermal injury to the left main coronary artery causing st elevations requiring a stent and prolonged hospitalization.After coming off radiofrequency (rf) on their first application on the aortic root on the left side, a left main coronary thermal injury occurred.The caller reported that the injury was discovered when the patient's ekg displayed st-segment elevation and qt prolongation.The injury was confirmed when the interventionalist came in to shoot the left main coronary artery and confirmed there to be some thermal damage that was occluding the vessel.A stent was provided as the medical intervention.The patient was reported to be in stable condition.This adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event was that it was procedure related.The cause of the complication was a direct result of ablation performed, but not a product issue.It was also patient condition related (location of the idiopathic vt/pvc origin).The patient outcome of the adverse event was improved.After emergency intervention, the patient was stable but lasting condition of patient is unknown at the time of the call.Overall patient in a worse position since a stent was required.The patient required extended hospitalization because of the adverse event.An emergency stent was placed, the patient stayed for a few additional days for additional monitoring.The generator used in the case was a smartablate generator.

Manufacturer Narrative

(b)(4).The device has been reported as discarded, 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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.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: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Type of Device: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• 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: 15325836
• MDR Text Key: 298950271
• Report Number: 2029046-2022-02052
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/31/2022

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 Model Number: BN7TCDF4L
• Device Catalogue Number: BN7TCDF4L
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/03/2022
• Initial Date FDA Received: 08/31/2022
• 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: SMARTABLATE GENERATOR KIT-US
• Patient Outcome(s): Required Intervention; Hospitalization; Life Threatening
• Patient Age: 15 YR
• Patient Sex: Male
• Patient Weight: 43 KG