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

Model Number 87121

Device Problem Temperature Problem (3022)

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

Event Date 09/08/2023

Event Type  malfunction  

Manufacturer Narrative

The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If there is any further relevant information obtained, a supplemental medwatch will be filed.

Event Description

It was reported that a blazer prime catheter presented an issue.The catheter doesn't reach the selected temperature.The device was replaced, and the procedure was completed successfully.No patient complications occurred.Delivery of ablation with lower than intended temperature may result in ineffective treatment and/or damage to the target tissue.The catheter is expected to be returned for analysis.

Event Description

It was reported that a blazer prime catheter presented an issue.The catheter doesn't reach the selected temperature.The device was replaced, and the procedure was completed successfully.No patient complications occurred.The device has been received at a boston scientific post market laboratory.

Manufacturer Narrative

Blazer prime catheter was evaluated by boston scientific.Visual inspection noted that the device does not have visual defects.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.The continuity test was performed, and the device was found under specification.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.Therefore, since no damages were found on the returned device and there is no evidence enough, it is determined that the most probable cause cannot be confirmed due to the lack of information.The complaint is classified as "no problem detected" due the investigation findings do not lead to the device complaint or problem confirmation.

• Brand Name: BLAZER PRIME HTD
• 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: 17864484
• MDR Text Key: 324844443
• Report Number: 2124215-2023-50465
• Device Sequence Number: 1
• Product Code: LPB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 12/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/03/2023
• 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: 0031239968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Manufacturer Received: 11/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1