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

Model Number	85016
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2020
Type of Reportable Event	Malfunction
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.
Event or Problem Description
It was reported that the catheter temperature increased.The blazer ii catheter was selected for a ablation procedure to treat ventricular extrasystole.After several ablations the temperature of the catheter was observed to increase by 20 degrees per second several times and effective energization could not be performed.The procedure was completed using a different device with no adverse patient effects being reported.
Additional Manufacturer Narrative
The returned device was reported for high temperature readings.Visual inspection of the device confirmed that there are no broken, bent or missing pins in the connector cable.Electrical testing of the returned device revealed that the device passed electrical testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that the catheter temperature increased.The blazer ii catheter was selected for a ablation procedure to treat ventricular extrasystole.After several ablations the temperature of the catheter was observed to increase by 20 degrees per second several times and effective energization could not be performed.The procedure was completed using a different device with no adverse patient effects being reported.

• 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: 10355773
• Report Number: 2134265-2020-10349
• Device Sequence Number: 19639079
• Product Code: LPB
• UDI-Device Identifier: 08714729199946
• UDI-Public: 08714729199946
• 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,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2020

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: 07/25/2022
• Device Model Number: 85016
• Device Catalogue Number: 85016
• Device Lot Number: 0024174152
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/12/2020
• Initial Date Received by Manufacturer: 07/21/2020
• Supplement Date Received by Manufacturer: 08/25/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1