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	02/21/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since the product was not returned for analysis, no product failure analysis can be conducted and no determination of possible contributing factors could be made.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.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient underwent an ablation procedure for supraventricular tachycardia (svt) with an ez steer¿ nav bi-directional electrophysiology catheter and suffered a heart block av requiring surgical intervention.During ablation, a heart block (degree-unspecified) was confirmed via electrocardiogram.A permanent pacemaker was implanted.Post-pacemaker, the patient was reported to be in stable condition and had returned to baseline.Patient required an overnight stay in the hospital to recover from pacemaker implantation.Patient fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was related to patient condition, as medical history includes bradycardia, syncope, and heart block.
Additional Manufacturer Narrative
The bwi failure analysis lab received the device for evaluation on 04/17/2018.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.Manufacturer's ref.No: (b)(4).
Additional Manufacturer Narrative
It was reported that a (b)(6) year-old female patient underwent an ablation procedure for supraventricular tachycardia (svt) with an ez steer¿ nav bi-directional electrophysiology catheter and suffered a heart block av requiring surgical intervention.The device was visually inspected and it was found in good conditions.Electrical test 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.Then, deflection test was performed and it was found within specifications, the catheter was deflecting correctly.The device history record (dhr) was reviewed and no anomalies were found related to this complaint.In addition, the dhr review verifies that the device was manufactured in accordance with documented specification and procedures.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.Manufacturer's 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: 7355651
• Report Number: 2029046-2018-01335
• Device Sequence Number: 16650122
• 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,Followup
• Report Date (Section B): 02/21/2018

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: 01/07/2021
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30003758M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2018
• Initial Date Received by Manufacturer: 02/21/2018
• Supplement Date Received by Manufacturer: 02/21/2018; 02/21/2018
• Initial Report FDA Received Date: 03/20/2018
• Supplement Report FDA Received Date: 04/26/2018; 05/18/2018
• 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
• Patient Age: 78 YR