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

Model Number	87069
Medical Device Problem Code	Output below Specifications (3004)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/13/2023
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
During a procedure, a intellanav st was selected for use.It was reported that a during ablation the power could not increase to 5w-10w despite multiple attempts.No error codes were displayed.After many attempts, the physician replaced the catheter.No patient complications occurred.No further information was provided.The device is expected to be returned for analysis.
Additional Manufacturer Narrative
Visual inspection revealed no defects.The steering knob and the tension control knob functioned properly on both lock and unlock positions.No abnormal resistance was felt when actuating the steering mechanism.Electrical continuity test was performed and the device was found within specifications.No open or shorts were detected.Rf ablation testing was verified by using the maestro generator 4000, and the device was found within specifications.During product analysis no damages were noticed on the returned device, the failures reported by the customer could not be confirmed.
Event or Problem Description
During a procedure, a intellanav st was selected for use.It was reported that a during ablation the power could not increase to 5w-10w despite multiple attempts.No error codes were displayed.After many attempts, the physician replaced the catheter.No patient complications occurred.No further information was provided.The device has been returned for analysis.

• 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: 16714635
• Report Number: 2124215-2023-15522
• Device Sequence Number: 7274636
• 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,Foreign,User Facility
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/10/2023
• Initial Report FDA Received Date: 04/11/2023
• Supplement Report FDA Received Date: 06/01/2023
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown