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

Model Number	85056
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on january 12, 2022.During a procedure to treat tachycardia a blazer ii htd catheter was selected for use.It was reported that there was no electric potential after the catheter entered body.Catheter connection was normal.The catheter was replaced and the procedure was completed successfully with no patient complications.However, device analysis revealed a circular cut in the distal section over the catheter shaft.
Additional Manufacturer Narrative
The device was returned to boston scientific for analysis.Visual inspection revealed a kink in the distal section between ring #2 and ring #3.Additionally it was observed a circular cut in the distal section over the catheter shaft was 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 test was performed and the device is out of specification.The thermistor was found open electrically.Ablation testing cannot be carried out because the thermistor is electrically open.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.It was confirmed this device met specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.

• 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: 13508374
• Report Number: 2134265-2022-01450
• Device Sequence Number: 17402979
• Product Code: LPB
• UDI-Device Identifier: 08714729172048
• UDI-Public: 08714729172048
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Foreign,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/10/2022

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: 10/31/2021
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0022879097
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/12/2022
• Initial Report FDA Received Date: 02/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 53 KG