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 Consequences Or Impact To Patient (2199)
Date of Event	08/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a blazer ii htd was used in a atrial fibrillation (af) radiofrequency ablation procedure.When the catheter was introduced into the there was no temperature perception.It was also reported that no error messages were displayed.No patient complications were reported.
Additional Manufacturer Narrative
The returned device was reported for the catheter having inaccurate temperature perception.Visual inspection of the device revealed no visual damages were found in the device.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 electrical test was performed and no short circuits were detected.However an intermittent opened circuit was detected in the thermistor line.The opened circuit was isolated and it was located in the joint between the connector wire and the thermistor line.The ablation test was not possible to be performed due to it showed the error d06-temp out of range.The joint where the opened circuit was dissembled and it was discovered that the wire and the thermistor line were not correctly attached.
Event or Problem Description
It was reported that a blazer ii htd was used in a atrial fibrillation (af) radiofrequency ablation procedure.When the catheter was introduced into the there was no temperature perception.It was also reported that no error messages were displayed.No patient complications were reported.

• 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
• MDR Report Key: 10678254
• Report Number: 2134265-2020-14185
• Device Sequence Number: 19489871
• 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
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2020

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: 06/18/2022
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0023981420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Initial Date Received by Manufacturer: 09/17/2020
• Supplement Date Received by Manufacturer: 11/05/2020
• Initial Report FDA Received Date: 10/14/2020
• Supplement Report FDA Received Date: 12/02/2020
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 60