MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV ST; 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	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was indicated that the device will not be returned for evaluation.If there is any further relevant information obtained, a supplemental medwatch will be filed.
Event or Problem Description
The intellanav stablepoint open-irrigated catheter (stablepoint) was selected for use during the radio frequency ablation procedure to treat repeated supraventricular tachycardia.It was reported that the temperature of the device could not reach the set value, it would not rise.The device was exchanged with a new one from the same model and the procedure was completed succesfully.No damage and no patient complications were noted.The device is not expected to be returned for analysis.
Event or Problem Description
The intellanav stablepoint open-irrigated catheter (stablepoint) was selected for use during the radio frequency ablation procedure to treat repeated supraventricular tachycardia.It was reported that the temperature of the device could not reach the set value, it would not rise.The issue was persistent.The device was exchanged with a new one from the same model and the procedure was completed succesfully.No damage and no patient complications were noted.The device was returned for analysis.
Additional Manufacturer Narrative
The returned intellanav stablepoint open-irrigated catheter was analyzed, passed all tests performed, and exhibited normal device characteristics.The reported event was not confirmed.No damages were noticed on the returned device.It was confirmed this device met manufacturing specification prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.There is no evidence that the device was used in a manner inconsistent with the labelled indications/ifu.

• Brand Name: INTELLANAV ST
• 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: 17185684
• Report Number: 2124215-2023-30824
• Device Sequence Number: 6495006
• Product Code: LPB
• UDI-Device Identifier: 08714729963974
• UDI-Public: 08714729963974
• 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,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/19/2023

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: 08/08/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0027805761
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2023
• Supplement Date Received by Manufacturer: 07/05/2023
• Initial Report FDA Received Date: 06/22/2023
• Supplement Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/09/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Unknown
• Patient Weight: 67 KG