MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION BLAZER II; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 85020

Device Problems Thermal Decomposition of Device (1071); High impedance (1291)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/14/2019

Event Type  malfunction  

Event Description

It was reported that catheter charring occurred.During an ablation procedure with a blazer ii ablation catheter, the initial impedance in the iliac vein was very high (230 ohms) and about ten radiofrequency shots were performed at low power (10 watts).Upon removal of the catheter, it's tip was noted to be charred.A second device of the same batch was placed but since the initial impedance was high, no shot was performed.A third device from another batch was used and this was functional.There were no consequences for the patient.

Manufacturer Narrative

The device was returned for analysis.Overall visual revision did not identify failures or evidence that could be lost due to decontamination process.Visual inspection revealed char observed on the tip in distal end.Functional inspection revealed the steering knob and tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Electrical test revealed d02-high impedance message appeared on the maestro 4000 screen, since the distal tip section with char was in touch with the connection fixture, therefore, the section of the tip with char was replaced making the electrical contact with the fixture and running the test without issues.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.

Event Description

It was reported that catheter charring occurred.During an ablation procedure with a blazer ii ablation catheter, the initial impedance in the iliac vein was very high (230 ohms) and about ten radiofrequency shots were performed at low power (10 watts).Upon removal of the catheter, it's tip was noted to be charred.A second device of the same batch was placed but since the initial impedance was high, no shot was performed.A third device from another batch was used and this was functional.There were no consequences for the patient.

• Brand Name: BLAZER II
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 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: 8395703
• MDR Text Key: 137993441
• Report Number: 2134265-2019-02127
• 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: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 04/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/11/2021
• Device Model Number: 85020
• Device Catalogue Number: 85020
• Device Lot Number: 22787528
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: BLAZER II