MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number NI75TCDH

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Cardiac Tamponade (2226)

Event Date 10/11/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter phone: (b)(6).The device has been reported as discarded, therefore no product investigation can be performed, and the customer complaint cannot be confirmed.A manufacturing record evaluation was performed for the finished device 30572172m number, and no internal action related to the complaint was found during the review.If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number: (b)(4).

Event Description

It was reported that a female patient born (b)(6) underwent an atrioventricular nodal reentrant tachycardia (avnrt) ablation procedure with a navistar¿ electrophysiology catheter.The patient suffered heart block which required steroids and pacing.During the ablation they caused a heart block mobitz type ii.They were about 10 mm away from the his while they were ablating.The caller states they lost conduction to the ventricle.They paced the patient via the rv catheter and they had retrograde conduction.They knew they did not take out the fast pathway.They think they may have stimulated the parasympathetic nervous system.The patient was being monitored and she did start to recover a little bit.The reporter states they will find out tomorrow if the patient made a full recovery.When the patient left the lab they were not being paced.The reporter states the patient received some isopropyl.The patient had some prolongation and they are slowly recovering.The patient was starting to pace on their own and they were in first-degree heart block.The patient is stable and they are staying overnight for observation.The physician felt they may have stimulated the parasympathetic nervous system and the treatment was steroids.The physician was planning to give the patient the steroid for the treatment.They used a 4mm nav, cs, and an hra, his, and rv catheter.It was also reported that during the procedure, in the beginning, they received a 105 catheter sensor error.The staff stated the physician had disconnected and reconnected the catheter from the cable and the error was displayed.They replaced the cable and the issue was resolved and the case continued.Additional information: this adverse event was discovered during use of biosense webster products.The physician¿s opinion on the cause of this adverse event: patient condition.Intervention provided: rv pacing and isopropyl.Patient outcome of the adverse event: fully recovered (no residual effects).Since the event is life threatening and required cancellation of the procedure to prevent permanent impairment of a body function or permanent damage to a body structure, is to be considered serious and mdr-reportable.

• Brand Name: NAVISTAR¿ ELECTROPHYSIOLOGY CATHETER
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• Manufacturer (Section D): BIOSENSE WEBSTER INC; 31 technology drive, suite 200; irvine CA 92618
• MDR Report Key: 12749985
• MDR Text Key: 280073858
• Report Number: 2029046-2021-01875
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 10846835000559
• UDI-Public: 10846835000559
• Combination Product (y/n): N
• PMA/PMN Number: P030031
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/03/2021

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: 05/31/2024
• Device Model Number: NI75TCDH
• Device Catalogue Number: NI75TCDH
• Device Lot Number: 30572172M
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 10/12/2021
• Initial Date FDA Received: 11/04/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2021
• 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
• Treatment: CARTO 3 SYSTEM; NGEN GENERATOR; PENTARAY NAV ECO; THERMOCOOL SMARTTOUCH CATHETER; VISITAG MODULE
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention
• Patient Age: 69 YR
• Patient Weight: 78