MAUDE Adverse Event Report: BIOSENSE WEBSTER INC. THERMOCOOL SMARTTOUCH SF; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number D134804

Device Problem Unable to Obtain Readings (1516)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Event Description

When ablation catheter was placed in the body, it would not display the temperature while attempting to ablate.From the procedural note: right femoral access was obtained under ultrasound guidance.A 7 fr, 11 fr, and 8 fr short sheaths were inserted into the right femoral vein utilizing the modified seldinger technique.The intracardiac echo catheter was placed within the 11 fr short sheath, advanced into the heart using ultrasound guidance.A 3d sound map of the left atrium and pulmonary veins were made.The 8 fr short sheath was exchanged for an 8.5 fr long vizigo sheath, through which, a pentaray catheter was placed and advanced into the heart using 3-dimensional mapping with carto.A 3d map of the right atrium, right ventricle, his bundle, and coronary sinus was made.A decapolar catheter was placed within the 7 fr short sheath and advanced into the heart using 3d mapping with carto, placed into the coronary sinus where it remained for the entirety of the case.The vizigo sheath was then used for transseptal access utilizing pressure monitoring (la [left atrial] pressure was 15/ 8/ 10 mmhg), 3d mapping with carto and ultrasound guidance.A 3d voltage map of the la was made revealing severe heterogeneity in electrogram voltage in the body of the left atrium with all four veins connected at onset.Wide antral circumferential ablation was performed with first pass isolation.After isolation of the right veins the patient converted from af to typical, ccw (counterclockwise) atrial flutter confirmed by activation mapping.Cavo-tricuspid ablation was performed with conversion to sinus bradycardia.There were no patient complications.

• Brand Name: THERMOCOOL SMARTTOUCH SF
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BIOSENSE WEBSTER INC.; 5110 commerce rd; baldwin park CA 91706
• MDR Report Key: 11265393
• MDR Text Key: 229835074
• Report Number: 11265393
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 10846835010176
• UDI-Public: (01)10846835010176(17)211013(10)30452630M
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: D134804
• Device Catalogue Number: D134804
• Device Lot Number: 30452630M
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 01/19/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/02/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 29565 DA
• Patient Weight: 68