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); Pneumothorax (2012); Rupture (2208); Cardiac Tamponade (2226)

Event Date 12/13/2021

Event Type  Injury  

Manufacturer Narrative

This complaint is from a literature source.Literature citation: jurcevic r, angelkov l, tasic n, tomovic m, kojic d, otasevic p, bojic m.Pulmonary vein isolation outcome degree is a new score for efficacy of atrial fibrillation catheter ablation.J clin med.2021 dec 13;10(24):5827.Doi: 10.3390/jcm10245827.Pmid: 34945124; pmcid: pmc8708501.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.This report is being submitted pursuant to the provisions of 21 cfr, part 4.This report may be based on information which has not been investigated or verified prior to the required reporting date.This report does not reflect a conclusion by biosense webster inc., or its employees that the report constitutes an admission that the product, biosense webster inc., or its employees caused or contributed to the potential event described in this report.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.The literature file is too large to attach.Manufacturer's ref #: (b)(4).

Event Description

This complaint is from a literature source.Literature citation: jurcevic r, angelkov l, tasic n, tomovic m, kojic d, otasevic p, bojic m.Pulmonary vein isolation outcome degree is a new score for efficacy of atrial fibrillation catheter ablation.J clin med.2021 dec 13;10(24):5827.Doi: 10.3390/jcm10245827.Pmid: 34945124; pmcid: pmc8708501.Objective/methods/study data: authors' study aimed to evaluate pulmonary vein isolation outcome degree (pviod) as a new semiquantitative measure for pvi success after a 7-year follow-up and to determine parameters for predicting the pviod.This prospective study included 124 consecutive patients with symptomatic af who underwent pvi from january 2012 to december 2013.Lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar thermocool concomitant other biosense webster devices that were also used in this study: pentaray catheter, carto3.Non-biosense webster devices that were also used in this study: n/a.Adverse event(s) and provided interventions possibly associated with ablation catheter: qty 1 rupture of mitral valve chordae treated with open heart surgery and mitral valvuloplasty.Qty 2 cardiac tamponades treated with pericardiocentesis.Qty 1 pneumothorax resolving with pleural drainage.Qty 1 stroke(cva) - intervention not discussed but considered a major complication.Qty 5 pericardial effusion managed conservatively.

• 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: 14701850
• MDR Text Key: 294954172
• Report Number: 2029046-2022-01324
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• 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
• Report Date: 06/15/2022

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: 05/20/2022
• Initial Date FDA Received: 06/15/2022
• 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: UNK_CARTO 3; UNK_PENTARAY
• Patient Outcome(s): Life Threatening; Required Intervention