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

Model Number 85056

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 01/29/2024

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

The blazer temperature ablation catheter was selected for use during the ablation procedure.It was reported that foreign substance was observed in the catheter handle.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.

Manufacturer Narrative

Device evaluated by manufacturer: the device was returned for analysis.Visual inspection was performed and the device has adhesive residue on the handler.Functional testing was performed and revealed that the steering knob and the tension control knob functioned properly.No abnormal resistance was felt when actuating the steering mechanism.With all the available information, boston scientific concludes the reported event of foreign substance on the catheter handle was confirmed.

Event Description

The blazer temperature ablation catheter was selected for use during the ablation procedure.It was reported that foreign substance was observed in the catheter handle.The device was replaced with a new one from the same model.The procedure was completed successfully without patient complications.The device is expected to be returned for analysis.

• Brand Name: BLAZER II HTD TEMPERATURE ABLATION CATHETER
• 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: 18751614
• MDR Text Key: 336763390
• Report Number: 2124215-2024-08591
• Device Sequence Number: 1
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: P920047
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/30/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0032296505
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/29/2024
• Initial Date FDA Received: 02/21/2024
• Supplement Dates Manufacturer Received: 04/13/2024
• Supplement Dates FDA Received: 04/30/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1