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

Catalog Number	BN7TCFF4L
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	01/15/2018
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.A manufacturing record evaluation was performed for the finished device 17713942m number, and no non-conformances related to the reported complaint condition were identified.(b)(4).
Event or Problem Description
It was reported that a (b)(6) male patient underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with an ez steer¿ nav bi-directional electrophysiology catheter and suffered heart block av requiring pacemaker implantation.During the procedure, the patient went into heart block av.A temporary pacemaker was implanted.No further intervention was required.There¿s no information regarding extended hospitalization or patient¿s outcome.There were no error messages noted on the equipments.Physician¿s opinion regarding the cause of the adverse event is that it was procedure-related.No further details are available.

• 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: 8312508
• Report Number: 2029046-2019-02659
• Device Sequence Number: 16591477
• Product Code: LPB
• UDI-Device Identifier: 10846835003017
• UDI-Public: 10846835003017
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 01/15/2019

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: 08/21/2020
• Device Catalogue Number: BN7TCFF4L
• Device Lot Number: 17713942M
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/15/2019
• Initial Report FDA Received Date: 02/06/2019
• 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: Required Intervention
• Patient Age: 54 YR