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

Model Number	87122
Medical Device Problem Codes	Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2023
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 during an ablation procedure that during an ablation procedure using a blazer prime htd the tip of the catheter fractured.During first use of the catheter the device fractured towards the tip of the device and sharp metal was exposed.They exchanged the catheter and the issue was resolved.The procedure was then completed with no patient complications.The catheters is expected to be returned for analysis.
Event or Problem Description
It was reported that during an ablation procedure using a blazer prime htd the tip of the catheter fractured.The first time the catheter was torqued the device fractured towards the tip of the device and sharp metal was exposed.The catheter was removed with no additional interventions.They exchanged the catheter, and the issue was resolved.The procedure was then completed with no patient complications.The catheters is expected to be returned for analysis.
Additional Manufacturer Narrative
The device has not been received for analysis.However, a photograph of the damaged catheter was provided, and analysis was performed based on that picture.Visual inspect of the image showed kinking in the distal portion of the catheter shaft.The extent of the kink or fracturing could not be determined.With all the available information boston scientific confirms the allegation of fracturing in this complaint.The most likely cause is adverse event related to the procedure, as it is likely that factors encountered during the procedure and/or the manner in which the device was handled could have caused the kink in the catheter.

• Brand Name: BLAZER PRIME 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: 17086897
• Report Number: 2124215-2023-28109
• Device Sequence Number: 19534500
• Product Code: LPB
• UDI-Device Identifier: 08714729803607
• UDI-Public: 08714729803607
• Combination Product (Y/N): N
• Initial Reporter Country: BL
• PMA/510(K) Number: P920047
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/05/2023

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: 02/10/2025
• Device Model Number: 87122
• Device Catalogue Number: 87122
• Device Lot Number: 0028850140
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/11/2023
• Supplement Date Received by Manufacturer: 06/08/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 07/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/11/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR
• Patient Sex: Female