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

Model Number BN7TCDF4L

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

Patient Problems Bradycardia (1751); Low Blood Pressure/ Hypotension (1914)

Event Date 02/24/2020

Event Type  Injury  

Manufacturer Narrative

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 patient underwent an atrioventricular reentrant (reentry) tachycardia (avrt) and wolff-parkinson-white (wpw) syndrome ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and developed a vagal episode requiring medication and fluid administration.During the ablation phase, the settings were 45 watts and 65-degree as temperature limiter.While ablating a steam pop occurred and about 5 minutes later, the patient had a vagal episode.Atropine and fluid were administered, and the patient recovered.No other adverse event from the steam pop was reported.When the case was over, the patient was reported in stable condition and without any distress.There¿s no indication that extended hospitalization was required as a result of the event.Physician¿s opinion regarding the cause of the adverse event is unknown.Multiple attempts were made to obtain further details regarding this event without response.Should more information become available in the future, it will be reviewed and processed accordingly.

Manufacturer Narrative

Device investigation details: 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 (mre) cannot be conducted because no lot number was provided by the customer.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: 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: 9850917
• MDR Text Key: 191608684
• Report Number: 2029046-2020-00442
• 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: 02/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2020
• 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
• Date Manufacturer Received: 06/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention