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	Swelling/ Edema (4577)
Date of Event	07/16/2021
Type of Reportable Event	Serious Injury
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
During an ablation procedure to treat supraventricular tachycardia a blazer ii htd catheter was selected for use.It was reported that the temperature did not meet the ablation requirements of the lesion.Repeated ablation attempts resulted in edema on the contact surface of the lesion."emergency treatment" might have been performed to treat the edema, however the details are unknown.The procedure was cancelled and rescheduled.No additional complications were reported and the patient's current condition is fine.
Additional Manufacturer Narrative
The device was received by boston scientific for analysis.Upon product analysis it was observed that the continuity test was performed, and the device was found within specifications.No opens or shorts were found.The ablation was verified by using the maestro generator 4000, and the device was found within specifications.Based on the information provided, there is no evidence that the device was used in a manner inconsistent with the labelled indications/instructions for use (ifu).The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
During an ablation procedure to treat supraventricular tachycardia a blazer ii htd catheter was selected for use.It was reported that the temperature did not meet the ablation requirements of the lesion.Repeated ablation attempts resulted in edema on the contact surface of the lesion."emergency treatment" might have been performed to treat the edema, however the details are unknown.The procedure was cancelled and rescheduled.No additional complications were reported and the patient's current condition is fine.

• 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: 12590986
• Report Number: 2134265-2021-12346
• Device Sequence Number: 4380473
• 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,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/21/2022
• Device Model Number: 85056
• Device Catalogue Number: 85056
• Device Lot Number: 0023838648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/16/2021
• Supplement Date Received by Manufacturer: 10/22/2021
• Initial Report FDA Received Date: 10/07/2021
• Supplement Report FDA Received Date: 11/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR
• Patient Sex: Male
• Patient Weight: 60 KG