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

Catalog Number	BN7TCFJ4L
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); No Code Available (3191)
Date of Event	02/21/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The bwi product analysis lab received the device for evaluation.The analysis has begun but is not completed at this time.When the investigational analysis has been completed, a supplemental 3500a report will be submitted.On 3/1/2019, a manufacturing record evaluation was performed for the finished device and no internal action related to the reported complaint were identified.(b)(4).
Event or Problem Description
It was reported that a female patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered heart block atrioventricular (av) requiring surgical intervention.During the ablation phase, there was a complete heart block.After coming off ablation, the patient was displaying some temporary av node function but has not completely recovered.Temporary pacemaker wire was initially implanted.Extended hospitalization was required.The patient was kept overnight for observation purposes.The native conduction did not come back, and permanent pacemaker was then implanted.Patient¿s condition improved after the placement of the permanent pacemaker.The physician did not express a specific opinion to me about what caused the adverse event.However, it is not believed that any biosense webster inc.Product attributed to the causality of the event.
Additional Manufacturer Narrative
It was reported that a female patient underwent an atrioventricular nodal reentry tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered heart block atrioventricular (av) requiring surgical intervention.The investigational analysis completed 4/17/2019.The device was visually inspected and it was found in good condition.The magnetic sensor was tested on carto and the catheter was properly visualized with no errors were observed.Electrical testing was performed on the catheter and it was found within specifications.No electrical malfunction was observed.Additionally, the catheter was tested on the generator and the temperature and impedance values were observed within specifications.Deflection testing was performed and it was found within specifications.The catheter was deflecting correctly.A manufacturing record evaluation was performed and no internal actions were identified.  the catheter passed all specifications.The root cause of the adverse event remains unknown.The instructions for use states that careful catheter manipulation must be performed to avoid cardiac damage, perforation or tamponade.Manufacture ref no: (b)(4).

• Brand Name: EZ STEER¿ NAV BI-DIRECTIONAL ELECTROPHYSIOLOGY CATHETER
• Common Device Name: ELECTRODE, PERCUTANEOUS, CONDUCTION TISSUE ABLATION
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 8435780
• Report Number: 2029046-2019-02845
• Device Sequence Number: 1795263
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: P990025/S12
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 12/03/2021
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30155325M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/18/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/17/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 04/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Disability