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	Complete Heart Block (2627); No Code Available (3191)
Date of Event	05/30/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
No device was received for analysis at the time of submission of the initial 3500a.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.The device history record (dhr) for the lot number 30012897m has been reviewed and it was verified that the device was manufactured in accordance with documented specifications and procedures.(b)(4).
Event or Problem Description
It was reported that a (b)(6) female patient weighing approximately (b)(6) underwent an ablation procedure for supraventricular tachycardia (svt)/atrioventricular nodal reentrant tachycardia (avnrt) with an ez steer¿ nav bi-directional electrophysiology catheter and suffered a heart block av requiring a surgical intervention.During ablation, the atrioventricular (av) node was inadvertently ablated.Heart block occurred and a pacemaker was inserted.Patient was reported to be in stable condition.Patient was transferred to the intensive care unit (icu) for observation and admitted to the hospital.While in the icu, patient¿s rhythm recovered and a permanent pacemaker was no longer necessary.Patient fully recovered with no residual effects.Physician¿s opinion regarding the cause of the adverse event is that it was related to patient movement during ablation.There were no issues, errors, or malfunctions reported on any biosense webster, inc.Products or equipment during the procedure.
Additional Manufacturer Narrative
Additional information was received on june 27, 2018 stating that while in the intensive care unit, after a 24hr period, the patient¿s rhythm recovered and a permanent pacemaker was no longer necessary.Originally, it was reported that the product was to be returned for evaluation.However, an update was received on june 27, 2018 stating that the device is not available for evaluation.The product was discarded, therefore no product failure analysis can be conducted and device malfunction cannot be confirmed.Manufacturer¿s reference number: (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: 7630579
• Report Number: 2029046-2018-01728
• Device Sequence Number: 19442000
• Product Code: LPB
• UDI-Device Identifier: 10846835003031
• UDI-Public: 10846835003031
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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): 05/30/2018

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: 01/25/2021
• Device Catalogue Number: BN7TCFJ4L
• Device Lot Number: 30012897M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/30/2018
• Supplement Date Received by Manufacturer: 06/27/2018
• Initial Report FDA Received Date: 06/22/2018
• Supplement Report FDA Received Date: 07/26/2018
• 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: 60 YR
• Patient Weight: 80