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

Catalog Number BN7TCDF4L

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problem Ventricular Fibrillation (2130)

Event Date 02/21/2019

Event Type  Injury  

Manufacturer Narrative

The product was discarded; therefore, no product failure analysis can be conducted and device malfunction cannot be confirmed.As such the investigation will be closed.If the complaint device is received in the future we will reopen the complaint and perform the investigation as appropriate.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Concomitant medical products: carto 3 system (us catalog # unknown, serial # unknown).Manufacturer's ref.# (b)(4).

Event Description

It was reported that a male patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and a preface® guiding sheath with multipurpose curve and suffered ventricular fibrillation (vf) requiring cardioversion and artery spasm requiring medication.The ablation procedure was successfully completed with no immediate patient consequences.No bwi product issues were reported.Post-procedure, the patient went into vf and required external cardioversion.A cardiac catheterization was performed and a ¿small vessel spasm¿ was noticed.Nitroglycerine was administered to solve the issue.No further issues occurred.The patient was reported to be stable and doing well the next day.Extended hospitalization was required for observation purposes.Throughout the ablation procedure, the patient did not experience chest pain or display any ecg changes.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.Patient¿s outcome is recovered.It is not believed at this time that a bwi product is responsible for the issue seen.Biosense webster manufacturer's reference number (b)(4) has two reports related to the same incident: mfr # 2029046-2019-02821 for product code 301803m (preface® guiding sheath with multipurpose curve) , this report # for product code bn7tcdf4l (ez steer¿ nav bi-directional electrophysiology catheter) this mdr is for the ez steer¿ nav bi-directional electrophysiology catheter for the adverse event of ventricular fibrillation.

Manufacturer Narrative

On 3/15/2019, it was noted a correction is needed to correct information reported in the event description of initial 3500a.The correct statement should say: "biosense webster manufacturer's reference number (b)(4) has two reports related to the same event: mfr # 2029046-2019-02821 for product code 301803m (preface® guiding sheath with multipurpose curve).(2) mfr # 2029046-2019-02822 for product code bn7tcdf4l (ez steer¿ nav bi-directional electrophysiology catheter)".Manufacturer's ref # (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.; 33 technology drive; irvine CA 92618
• MDR Report Key: 8426282
• MDR Text Key: 138994620
• Report Number: 2029046-2019-02822
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835002997
• UDI-Public: 10846835002997
• Combination Product (y/n): N
• PMA/PMN Number: P990025/S12
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: BN7TCDF4L
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention