MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II XP; CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER

Model Number 85270

Device Problems Difficult to Remove (1528); Material Deformation (2976)

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

Event Date 09/08/2022

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 a procedure using a blazer ii xp catheter the shaft bentand became lodged in the inferior vena cava (ivc).During preparation the catheter exhibited no abnormal characteristics and no abnormal resistance was felt while using it during the procedure prior to the issue.The shaft of the catheter then became bent, and possibly fractured.Once bent in this manner the catheter was then found to be lodged in the ivc.They were not able to remove the catheter on its own so the physician had to use an extraction system.The procedure was completed and there were no patient complications.The catheter is expected to be returned for analysis.

Manufacturer Narrative

Previous evaluation had been conducted on images of the device in question.Additional investigation was performed as the actual catheter was received by boston scientific upon receipt at boston scientific's post market laboratory the catheter was first visually inspected, and three kinks were identified.All three kinks were within 11 cm of the distal tip of the catheter.They then tested the steering of the catheter and found the steering controls to be functional, however, the catheter was not able to fully reach the expected curve in either direction.Pictures that were provided with the initial event report also confirmed the presence of the kinks.A history review of the catheter confirmed that they met specification prior to distribution.

Event Description

It was reported that during a procedure using a blazer ii xp catheter the shaft bent/ fractured and became lodged in the inferior vena cava (ivc).During preparation the catheter exhibited no abnormal characteristics and no abnormal resistance was felt while using it during the procedure prior to the issue.The shaft of the catheter then became bent, possibly fractured.Once bent in this manner the catheter was then found to be lodged in the ivc.They were not able to remove the catheter on its own so the physician had to use an extraction system.The procedure was completed and there were no patient complications.The catheter has been received at boston scientific's post market laboratory where it is awaiting analysis.

Manufacturer Narrative

The device was not returned to boston scientific for analysis; however, images of the device were made available for investigation.Upon review of these images, it was concluded that the allegation of kinks in the catheter was confirmed.There were two bends in the distal part of the catheter shaft.A history review of the catheter confirmed that they met specification prior to distribution.With all the available information the most likely cause was traced to adverse event related to the procedure.It was noted in the complaint that the catheter was not kinked or difficult to use during preparation for the procedure, it is possible the kinks in the shaft were caused by factors encountered during the procedure or in the way the device was handled.

Event Description

It was reported that during a procedure using a blazer ii xp catheter the shaft bent and became lodged in the inferior vena cava (ivc).During preparation the catheter exhibited no abnormal characteristics, and no abnormal resistance was felt while using it during the procedure prior to the issue.The shaft of the catheter then became bent, possibly fractured.Once bent in this manner the catheter was then found to be lodged in the ivc.They were not able to remove the catheter on its own so the physician had to use an extraction system.The procedure was completed and there were no patient complications.The catheter is expected to be returned for analysis.

• Brand Name: BLAZER II XP
• Type of Device: CATHETER, PERCUTANEOUS, CARDIAC ABLATION, FOR TREATMENT OF ATRIAL FLUTTER
• 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: 15462064
• MDR Text Key: 300320405
• Report Number: 2124215-2022-37159
• Device Sequence Number: 1
• Product Code: OAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/21/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/25/2022
• Device Model Number: 85270
• Device Catalogue Number: 85270
• Device Lot Number: 0024494745
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention