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 Pulmonary Embolism (1498); Fistula (1862); Cardiac Tamponade (2226)

Event Date 07/25/2020

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: ghannam m, yokokawa m, liang jj, cochet h, jais p, dabagh gs, latchamsetty r, jongnarangsin k, morady f, bogun f.Clinical significance of myocardial scar in patients with frequent premature ventricular complexes undergoing catheter ablation.Heart rhythm.2021 jan;18(1):20-26.Doi: 10.1016/j.Hrthm.2020.07.030.Epub 2020 jul 25.Pmid: 32721479.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.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: ghannam m, yokokawa m, liang jj, cochet h, jais p, dabagh gs, latchamsetty r, jongnarangsin k, morady f, bogun f.Clinical significance of myocardial scar in patients with frequent premature ventricular complexes undergoing catheter ablation.Heart rhythm.2021 jan;18(1):20-26.Doi: 10.1016/j.Hrthm.2020.07.030.Epub 2020 jul 25.Pmid: 32721479.Objective/methods/study data: the purpose of this study was to determine the impact of focal myocardial scarring as detected by cardiac magnetic imaging on premature ventricular complexes induced cardiomyopathy, procedural outcomes, and recovery of left ventricular function in patients with frequent premature ventricular complexes.A total of 351 consecutive patients with frequent premature ventricular complexes referred for ablation were included.A cardiac magnetic resonance was performed in all patients prior to the ablation procedure.A =10% increase in ejection fraction or normalization of a previously abnormal ejection fraction was defined as evidence of premature ventricular complexes induced cardiomyopathy.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: thermocool navistar concomitant other biosense webster devices that were also used in this study: carto concomitant non-biosense webster devices that were also used in this study: signa excite cv/i (general electric), 5 t achieva mri (philips), workmate claris (abbott) adverse event(s) and provided interventions: there were 6 major procedural complications including: qty 4: cardiac perforations treated with pericardial drains.Qty 1: av fistula requiring surgical repair.Qty 1: pulmonary embolism.

• 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 ; 646591-798
• MDR Report Key: 14388276
• MDR Text Key: 292164362
• Report Number: 2029046-2022-01019
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/12/2022

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: 04/20/2022
• Initial Date FDA Received: 05/13/2022
• 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: 5 T ACHIEVA MRI (PHILIPS); CARTO; SIGNA EXCITE CV/I (GENERAL ELECTRIC); WORKMATE CLARIS (ABBOTT)
• Patient Outcome(s): Life Threatening; Required Intervention