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

Model Number	85105
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/15/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that when the temperature increased, and output did not display.During a catheter ablation procedure to treat paroxysmal supraventricular tachycardia in the left inguinal, left subclavian a blazer ii catheter was selected for use.After the device was inserted inside the body, energization was tried to perform with the catheter, but the temperature increased, and output did not display.The catheter was replaced and the procedure was completed without patient complications.
Additional Manufacturer Narrative
Visual inspection revealed the device does not have visual defects.The functional testing revealed no abnormal resistance was felt when actuating the steering mechanism.The electrical testing revealed the device was found within specification.No opens or shorts were found.The radio frequency ablation test was verified by using the maestro generator 4000, and the device was found within specifications.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/dfu.
Event or Problem Description
It was reported that when the temperature increased, and output did not display.During a catheter ablation procedure to treat paroxysmal supraventricular tachycardia in the left inguinal, left subclavian a blazer ii catheter was selected for use.After the device was inserted inside the body, energization was tried to perform with the catheter, but the temperature increased, and output did not display.The catheter was replaced and the procedure was completed without patient complications.

• Brand Name: BLAZER II
• Common Device Name: CARDIAC ABLATION PERCUTANEOUS CATHETER
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10046488
• Report Number: 2134265-2020-06317
• Device Sequence Number: 2900020
• Product Code: LPB
• UDI-Device Identifier: 08714729301707
• UDI-Public: 08714729301707
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/22/2020

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: 07/03/2021
• Device Model Number: 85105
• Device Catalogue Number: 85105
• Device Lot Number: 0022336045
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2020
• Initial Date Received by Manufacturer: 04/15/2020
• Supplement Date Received by Manufacturer: 05/26/2020
• Initial Report FDA Received Date: 05/12/2020
• Supplement Report FDA Received Date: 06/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1