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

Model Number 85275

Device Problem Material Perforation (2205)

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

Event Date 06/01/2022

Event Type  malfunction  

Event Description

It was reported that during an ablation procedure using a blazer ii xp the "device ruptured".They also mentioned impedance drop and more power.They replaced the device, however, no information about if the procedure was completed or if there were any patient complications were reported.Requests have been sent for information about the nature of the failure and the patient's status.The catheter is expected to be returned for analysis.

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.

Manufacturer Narrative

The blazer ii xp was returned for analysis.No visual defects were observed.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.Electrical continuity testing revealed that the device is within specification.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.The device passed all tests performed, and exhibited normal device characteristics.

Event Description

It was reported that during an ablation procedure using a blazer ii xp the "device ruptured".They also mentioned impedance drop and more power.They replaced the device, however, no information about if the procedure was completed or if there were any patient complications were reported.Requests have been sent for information about the nature of the failure and the patient's status.The catheter has been 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: 14881481
• MDR Text Key: 302712536
• Report Number: 2134265-2022-07562
• 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: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 09/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85275
• Device Catalogue Number: 85275
• Device Lot Number: 0028913831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/05/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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