MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV ST ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 87069

Device Problem Temperature Problem (3022)

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

Event Date 10/29/2021

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that during an ablation procedure to treat atrial tachycardia using an intellanav st ablation catheter they were unable to reach the desired temperature with a non-boston scientific generator.In addition there were impedance issues noted.They first changed the cable for the catheter, but that did not resolve the issue.They then replaced the catheter with a non-boston scientific catheter and were able to complete the procedure without patient complications.The catheter is expected to be returned for analysis.

Event Description

It was reported that during an ablation procedure to treat atrial tachycardia using an intellanav st ablation catheter they were unable to reach the desired temperature with a non-boston scientific generator.In addition there were impedance issues noted.They first changed the cable for the catheter, but that did not resolve the issue.They then replaced the catheter with a non-boston scientific catheter and were able to complete the procedure without patient complications.The catheter has received by boston scientific for analysis.

Manufacturer Narrative

Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected and no abnormalities were found.The steering and tension knobs were functionally tested and no abnormal resistance or movements were found.Then the circuitry of the device was tested and no electrical opens or shorts were identified.The catheter was within specification for all tests performed after the device's return.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV ST ABLATION CATHETER
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 302 parkway, global park; la aurora - heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 12805434
• MDR Text Key: 280944499
• Report Number: 2134265-2021-14282
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 01/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/26/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0026882266
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/13/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/07/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/26/2021
• 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