MAUDE Adverse Event Report: BIOSENSE WEBSTER INC EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER; SIMILAR DEVICE BNI75TCDDH, PMA # P030031

Catalog Number UNK_EZ STEER THERMOCOOL

Device Problems Entrapment of Device (1212); Appropriate Term/Code Not Available (3191)

Patient Problems Mitral Insufficiency (1963); No Code Available (3191)

Event Date 02/28/2012

Event Type  Injury  

Manufacturer Narrative

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 the no lot number was provided by the customer.Concomitant products that used in this study: carto.Other products that used in this study: 5fr ep star fixed nogami curve catheter ((b)(6) lifeline).Manufacturer's ref.(b)(4).

Event Description

This complaint is from a literature source.It is reported that a (b)(6) man with recurrent vt underwent rf catheter ablation using 3.5 mm tip navistar thermocool ablation catheter.During procedure, catheter tip had deflected and fixed in the left ventricular basal area.Attempts to straighten the catheter tip failed, and repetitive gentle tractions and advancement with clockwise and counterclockwise rotation maneuvers to release the tip were unsuccessful and caused chest pain.Patient was referred to the cardiac surgery department, and underwent open-heart surgery, including catheter removal.The left atrium was opened and direct examination confirmed that the ablation catheter tip was severely entangled within the chordae of the anterior mv leaflet.The catheter was separated via incisions in some parts of mv chordae under direct vision.After removal, close examination of the catheter tip showed one connection cable had torn, and that the steel head had separated from the plastic body, and chordate was inserted in that narrow crack.After removal of the entrapped tip, patient underwent cryoablation and no recurrence of vt for 8 months follow ups.However, a transthoracic echocardiogram revealed mild to moderate eccentric mitral regurgitation due to the prolapsed medial portion of both mv leaflets.Patient¿s medical history includes alcohol septal ablation for hypertrophic cardiomyopathy with severe left ventricular outflow tract (lvot) obstruction, implantable cardioverter-defibrillator (icd) insertion, recurrent vt, atrial fibrillation.Title: ¿ablation catheter entrapment by chordae tendineae in the mitral valve during ventricular tachycardia ablation¿.Suspect device is a 3.5 mm tip navistar thermocool, however catalog and lot number is unknown.

• Brand Name: EZ STEER THERMOCOOL NAV BI-DIRECTIONAL CATHETER
• Type of Device: SIMILAR DEVICE BNI75TCDDH, PMA # P030031
• 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: joaquin kurz ; 33 technology drive; irvine, CA 92618 ; 949789-383
• MDR Report Key: 7031694
• MDR Text Key: 92038662
• Report Number: 2029046-2017-01142
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: KR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Health Professional
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/14/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: UNK_EZ STEER THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/17/2017
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention
• Patient Age: 46 YR