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	02/11/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an supraventricular velocity(svt) ablation procedure to treat atrial fibrillation using an intellanav st catheter, the rf power did not increase and was unable to reach the desired temperature output upon attempt to deliver ablation energy.The catheter was exchanged with another of same device.And the procedure was completed.No patient complications were reported.The catheter is expected to be returned for analysis.
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 supraventricular velocity (svt) ablation procedure to treat atrial fibrillation using an intellanav st catheter, the rf power did not increase and was unable to reach the desired temperature output upon attempt to deliver ablation energy.The catheter was exchanged with another of same device.And the procedure was completed.No patient complications were reported.The catheter is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at boston scientific's post market laboratory the catheter was first visually inspected and no defects were noted.Next they tested the catheter's functional mechanisms by testing the steering knob and tension control knob.Both knobs worked as expected and no abnormal resistances were felt.Next the electrical and magnetic functionality was tested, no open or shorts were detected, however, the magnetic field sensor resistances did not fall within specifications.They then dissected the catheter in order to determine the failure point of the magnetic sensor.The electrical opening was confirmed in the wires.Also the manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.With all available information the allegation was confirmed, as the electrical short could lead to the failure observed in the field.

• 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: 13672536
• Report Number: 2134265-2022-02488
• Device Sequence Number: 12087896
• 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): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/15/2022

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: 01/28/2024
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0026714660
• 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: 02/21/2022
• Supplement Date Received by Manufacturer: 03/30/2022
• Initial Report FDA Received Date: 03/04/2022
• Supplement Report FDA Received Date: 04/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/28/2021
• 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: 63 YR
• Patient Sex: Female
• Patient Weight: 66 KG