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

Catalog Number NS7TCFL174HS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Arrhythmia (1721); Not Applicable (3189)

Event Date 05/09/2018

Event Type  Injury  

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 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
• Type of Device: CATHETER, ELECTRODE RECORDING
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 33 technology drive; irvine CA 92618
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez 32599 ; MX 32599
• Manufacturer Contact: gabriel alfageme ; 33 technology drive; irvine, CA 92618 ; 949789-868
• MDR Report Key: 7573566
• MDR Text Key: 110231540
• Report Number: 2029046-2018-01646
• Device Sequence Number: 1
• Product Code: DRF
• UDI-Device Identifier: 10846835000610
• UDI-Public: 10846835000610
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P990025
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: Health Professional
• Device Expiration Date: 01/14/2021
• Device Catalogue Number: NS7TCFL174HS
• Device Lot Number: 30002865M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/09/2018
• Initial Date FDA Received: 06/06/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/15/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention