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

Model Number	85040
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Per visual inspection device present several cuts in the catheter shaft.Device passes functional test, 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 dimensional test was passed and both right and left curves reached the specified area of the template.Electrical testing revealed an open ring three electrode (r3) and thermistor.
Event or Problem Description
Reportable based on analysis completed on 7jul2022.A blazer ii was returned with no allegations against the device.However, returned device analysis found that cuts were observed on the distal part of the shaft.

• Brand Name: BLAZER II
• 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: 15193873
• Report Number: 2134265-2022-08415
• Device Sequence Number: 20242494
• Product Code: LPB
• UDI-Device Identifier: 08714729333364
• UDI-Public: 08714729333364
• Combination Product (Y/N): N
• Initial Reporter Country: US
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 08/09/2022

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: 10/12/2024
• Device Model Number: 85040
• Device Catalogue Number: 85040
• Device Lot Number: 0028194729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/04/2022
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/18/2022
• Initial Report FDA Received Date: 08/09/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown