MAUDE Adverse Event Report: BIOSENSE WEBSTER INC UNK_NAVISTAR RMT THERMOCOOL; CARDIAC ABLATION PERCUTANEOUS CATHETER

Catalog Number UNK_NAVISTAR RMT THERMOCOOL

Device Problems Entrapment of Device (1212); Patient Device Interaction Problem (4001)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/26/2021

Event Type  Injury  

Event Description

This complaint is from a literature source.The following literature cite has been reviewed: benali k, hammache n, sellal jm, mazen e, de chillou c.Catheter knot around the mitral valve apparatus: an exceptional complication of remote magnetic navigation.J cardiovasc electrophysiol.2022 jan;33(1):137-139.Doi: 10.1111/jce.15313.Epub 2021 dec 16.Pmid: 34897865.Objective/methods/study data: remote magnetic navigation (rmn) is as safe and effective as manual navigation for catheter ablation of ventricular arrhythmias.This case is the first description of a soft-tip ablation catheter entrapment in the mitral valve apparatus during an rmn ablation procedure.The tight knot created by the catheter around a mitral valve chordae required surgical removal.This complication, which has never been reported before, highlights the need for closer fluoroscopic monitoring when performing catheter loops inside the ventricles when using the rmn system lot, model and catalog number are not available, but the suspected biosense device possibly associated with reported adverse events: navistar thermocool rmt; biosense webster.Other biosense webster devices that were also used in this study: -carto system (biosense webster inc.).Non-biosense webster devices that were also used in this study: stereotaxis remote magnetic navigation (rmn).Adverse event(s) and provided interventions: fluoroscopy images revealed that the tip of the ablation catheter was entrapped within the mitral valve apparatus, appearing to make a knot around a mitral chordae tendineae.The probable mechanism at the origin of the knot formation.Gentle traction on the catheter and manual clockwise and counterwise rotations were attempted but failed to untie the knot.The patient required cardiac surgery to remove the catheter.The catheter was successfully cut and removed from the mitral valve apparatus.

Manufacturer Narrative

This complaint is from a literature source.The following literature cite has been reviewed: benali k, hammache n, sellal jm, mazen e, de chillou c.Catheter knot around the mitral valve apparatus: an exceptional complication of remote magnetic navigation.J cardiovasc electrophysiol.2022 jan;33(1):137-139.Doi: 10.1111/jce.15313.Epub 2021 dec 16.Pmid: 34897865.The literature article is too large to attach.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 lot number was provided by the customer.Manufacturer¿s reference number: pc-(b)(4).

• Brand Name: UNK_NAVISTAR RMT THERMOCOOL
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• 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 32599 ; MX 32599
• Manufacturer Contact: michelleann garcia ; 31 technology dr; irvine, CA 92618 ; 646591-798
• MDR Report Key: 14640871
• MDR Text Key: 294858406
• Report Number: 2029046-2022-01238
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: 06/08/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK_NAVISTAR RMT THERMOCOOL
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2022
• 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 (BIOSENSE WEBSTER INC.); STEREOTAXIS REMOTE MAGNETIC NAVIGATION (RMN)
• Patient Outcome(s): Life Threatening; Required Intervention