MAUDE Adverse Event Report: BOSTON SCIENTIFIC DE COSTA RICA S.R.L. BLAZER PRIME HTD; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number 87121

Device Problems Poor Quality Image (1408); Temperature Problem (3022)

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

Event Date 08/28/2023

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 a blzr prime htd during procedure presented bad signal and an issue related with temperature, where this did not increase when it was needed.Because no more information was provided this event is interpreted as there was some temperature increase, but not enough to ablate effectively.As a solution is suspected by the sales representative that the device was replaced since the defective product was provided for return.The procedure was completed without patient complications.Regarding full name of the initial reporter, this information is not available.

Event Description

It was reported that a blzr prime htd during procedure presented bad signal and an issue related with temperature, where this did not increase when it was needed.Because no more information was provided this event is interpreted as there was some temperature increase, but not enough to ablate effectively.As a solution is suspected by the sales representative that the device was replaced since the defective product was provided for return.The procedure was completed without patient complications.Regarding full name of the initial reporter, this information is not available.

Manufacturer Narrative

The returned blzr prime htd was analyzed, passed all tests performed, and exhibited normal device characteristics.Visual inspection noted the device does not have visual defects.Functional test determined the steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Continuity test was performed, and the device is under specification.Electrical test verified the ablation by using the maestro generator 4000, and the device was found within specifications.

• Brand Name: BLAZER PRIME HTD
• Type of Device: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway, global park; la aurora - heredia ; CS
• 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: 17852391
• MDR Text Key: 324704189
• Report Number: 2124215-2023-50039
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: FI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 87121
• Device Catalogue Number: 87121
• Device Lot Number: 0030512730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/09/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1