MAUDE Adverse Event Report: BIOSENSE WEBSTER INC NAVI-STAR¿ THERMO-COOL¿ ELECTROPHYSIOLOGY CATHETER; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Catalog Number UNK_NAVISTAR THERMOCOOL

Device Problem Patient Device Interaction Problem (4001)

Patient Problems Stroke/CVA (1770); Fistula (1862); Hemorrhage/Bleeding (1888); Cardiac Tamponade (2226); Heart Block (4444)

Event Date 05/15/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: acosta j, soto-iglesias d, jáuregui b, armenta jf, penela d, frutos-lópez m, arana-rueda e, pedrote a, mont l, berruezo a.Long-term outcomes of ventricular tachycardia substrate ablation incorporating hidden slow conduction analysis.Heart rhythm.2020 oct;17(10):1696-1703.Doi: 10.1016/j.Hrthm.2020.05.017.Epub 2020 may 15.Pmid: 32417258.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.Device history record (dhr) review cannot be conducted because no lot number was provided by the customer.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: acosta j, soto-iglesias d, jáuregui b, armenta jf, penela d, frutos-lópez m, arana-rueda e, pedrote a, mont l, berruezo a.Long-term outcomes of ventricular tachycardia substrate ablation incorporating hidden slow conduction analysis.Heart rhythm.2020 oct;17(10):1696-1703.Doi: 10.1016/j.Hrthm.2020.05.017.Epub 2020 may 15.Pmid: 32417258.Objective/methods/study data: this study included 70 consecutive patients that underwent scar-related ventricular tachycardia ablation at 2 centers from june 2014 to april 2017.The purpose of this study was to analyze whether the elimination of hidden slow conduction electrograms during ventricular tachycardia substrate ablation results in better short- and long-term outcomes.Bipolar electrograms with more than 3 deflections and duration of less than 133 ms were considered as potential hidden slow conduction electrograms.Whenever a potential hidden slow conduction electrograms was identified, double or triple ventricular extra stimuli were delivered.If a local potential showed up as a delayed component, it was annotated as hidden slow conduction electrograms.Ablation was delivered at conducting channel entrances and hidden slow conduction electrograms.Radiofrequency time, ventricular tachycardia inducibility after ventricular fibrillation substrate ablation, and ventricular tachycardia /ventricular fibrillation recurrence at 24 months after the procedure were compared with data from a historical control group.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool navistar or smarttouch concomitant other biosense webster devices that were also used in this study: carto system, pentaray concomitant non-biosense webster devices that were also used in this study: n/a adverse event(s) and provided interventions: ablation-related major complications occurred in 5 patients (7.1%): qty 1: ischemic stroke within the first week of discharge.Qty 1: hemothorax due to injury to the internal mammary artery during pericardial puncture that required drainage.Qty 1: complete atrioventricular block.Qty 1: pericardial effusion that required drainage.Qty 1: arteriovenous fistula that required intervention before discharge.

Manufacturer Narrative

If additional information is received regarding this event, a supplemental 3500a report will be submitted to the fda.Manufacturer's reference number:(b)(4) during an internal review on 08-apr-2022, noted a correction to the 3500a initial as g3.Date received by manufacturer field was processed as 09-mar-2022 and it should have been 16-mar-2022.

• Brand Name: NAVI-STAR¿ THERMO-COOL¿ 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
• Manufacturer (Section G): BIOSENSE WEBSTER INC (JUAREZ); circuito interior norte; 1820parque industrial salvacar; juarez ; MX
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 6465917981
• MDR Report Key: 13985651
• MDR Text Key: 289508046
• Report Number: 2029046-2022-00706
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: SP
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2022

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 Catalogue Number: UNK_NAVISTAR THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/09/2022
• Initial Date FDA Received: 04/01/2022
• Supplement Dates Manufacturer Received: 04/08/2022
• Supplement Dates FDA Received: 04/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 SYSTEM; PENTARAY
• Patient Outcome(s): Required Intervention; Life Threatening