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

Model Number	85056
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/29/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during a procedure to treat a paroxysmal supraventricular tachycardia a blazer ii htd catheter was selected for use, however, the device presented an issue related to its sensor and a temperature error, therefore it was decided to replace the device and the issue was resolved.The procedure was completed.No patient complications were reported.
Additional 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.
Additional Manufacturer Narrative
Blazer ii htd catheter was evaluated by boston scientific.Visual inspection was performed, and no damages were observed.Functional test noted that 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 laboratory analysis was unable to confirm the reported clinical observations.The device was found within specifications.
Event or Problem Description
It was reported that during a procedure to treat a paroxysmal supraventricular tachycardia a blazer ii htd catheter was selected for use, however, the device presented an issue related to its sensor and a temperature error, therefore it was decided to replace the device and the issue was resolved.The procedure was completed.No patient complications were reported.The catheter was returned to boston scientific for laboratory analysis.

• Brand Name: BLAZER II HTD
• Common Device Name: 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: 17397398
• Report Number: 2124215-2023-38350
• Device Sequence Number: 7657918
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/02/2023

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
• Operator of Device: Health Professional
• Device Expiration Date: 02/28/2026
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0031150049
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/29/2023
• Supplement Date Received by Manufacturer: 09/06/2023
• Initial Report FDA Received Date: 07/26/2023
• Supplement Report FDA Received Date: 10/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Sex: Male