MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV ST ABLATION CATHETER; CARDIAC ABLATION PERCUTANEOUS CATHETER

Model Number	87069
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/20/2024
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 device presented poor temperature control.During procedure, an intellanav st ablation catheter was selected for use.It was observed that the power could not go up, and the temperature could only reach 30c.Catheter was replaced and the issue was resolved.The procedure was completed successfully.The patient condition following procedure was stable.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
The intellanav st ablation catheter was evaluated by boston scientific.Upon receipt at our post market quality assurance laboratory, device was visually inspected an no defects were noticed.Functional test shows that the catheter functional mechanism worked properly.No abnormal resistance was felt when actuating the device.The continuity test was performed and the device was found within specifications.No shorts or opens were detected.The ablation was verified by using the maestro generator 4000 and metriq, and the device was found within specifications.Laboratory analysis was unable to confirm the reported clinical observation of catheter poor temperature control.The device functioned as intended and was found within specifications.
Event or Problem Description
It was reported that the device presented poor temperature control.During procedure, an intellanav st ablation catheter was selected for use.It was observed that the power could not go up, and the temperature could only reach 30c.Catheter was replaced and the issue was resolved.The procedure was completed successfully.The patient condition following procedure was stable.The device is expected to be returned for analysis.

• Brand Name: INTELLANAV ST ABLATION CATHETER
• 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: mary crawford ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6514400979
• MDR Report Key: 20920744
• Report Number: 2124215-2024-78809
• Device Sequence Number: 12859594
• Product Code: LPB
• UDI-Device Identifier: 08714729963950
• UDI-Public: 08714729963950
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/21/2025

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: 06/28/2025
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0029679412
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/31/2025
• Initial Report FDA Received Date: 12/12/2024
• Supplement Report FDA Received Date: 02/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/29/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown