MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, ELECTRODE RECORDING

Catalog Number	NS7TCFL174HS
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Arrhythmia (1721); Not Applicable (3189)
Date of Event	05/09/2018
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.Concomitant products: carto 3 system (model # m-5830-01, serial# unknown).Pump (model# m-5491-01, lot# unknown).Webster coronary sinus catheter (model# d-1262-01-s, lot# unknown).Boston scientific catheter (model #unknown, lot# unknown).Generator (model# g4c-1878, serial# unknown).(b)(4).
Event or Problem Description
It was reported that a male patient underwent an ablation procedure for atrioventricular nodal reentrant tachycardia (avnrt) with a navistar¿ electrophysiology catheter and suffered a heart block av requiring surgical intervention.Prior to the procedure, the blue pin box was dropped and the housing that plugs into the patient interface unit (piu) was broken off.Pin box was replaced and the procedure continued.During the procedure, when the navistar catheter was being positioned near the atrioventricular (av) node/his region, the patient took a deep breath and intracardiac signals revealed a heart block.Right ventricular (rv) pacing was initiated.Temporary pacemaker was inserted.Patient was reported to be in stable condition.Patient will require 2-3 days of additional hospitalization as a result of the adverse event to monitor the av node.There is no patient outcome information.Physician¿s opinion regarding the cause of the adverse event is that it was related to the patient¿s condition and the deep breath the patient took while the navistar was being positioned near the av node/his region.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Common Device Name: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• MDR Report Key: 7573566
• Report Number: 2029046-2018-01646
• Device Sequence Number: 13507312
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P990025
• 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): 05/09/2018

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: 01/14/2021
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30002865M
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 06/06/2018
• 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