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

Model Number	87069
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2022
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 radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.
Event or Problem Description
During a radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.Furthermore, additional information clarified that when the physician stepped on the pedal, it was supposed to discharge constantly to ablate, but with this device, it would stopped automatically after a short while, and the physician had to step on the pedal again.The ablate could not be performed.Then the physician used another of same device and the issue no longer exist.
Additional Manufacturer Narrative
Additional information: b5.
Event or Problem Description
During a radiofrequency cardiac ablation a intellanav st was selected for use.The device discontinuous discharge and poor discharge.An exchange of the device resolved the problem.The procedure was completed without any patient complications.Furthermore, additional information clarified that when the physician stepped on the pedal, it was supposed to discharge constantly to ablate, but with this device, it would stopped automatically after a short while, and the physician had to step on the pedal again.The ablate could not be performed.Then the physician used another of same device and the issue no longer exist.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the catheter was visually inspected, and the device does not have any visual defects.The functional testing revealed 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.The continuity test was performed, and the device was found within specifications.No open or shorts were detected.The radio frequency ablation test was found to be within specifications.With all available information the complaint could not be confirmed as the reported failure was not able to be reproduced and the device presented with no issues.

• 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: 15658191
• Report Number: 2124215-2022-42988
• Device Sequence Number: 20448951
• 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: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/01/2023

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: 06/30/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0027596531
• 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: 09/29/2022
• Supplement Date Received by Manufacturer: 11/16/2022; 01/05/2023
• Initial Report FDA Received Date: 10/24/2022
• Supplement Report FDA Received Date: 12/13/2022; 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2021
• 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: 34 YR
• Patient Sex: Male
• Patient Weight: 87 KG