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 Codes	No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/14/2020
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 during an ablation procedure to treat supraventricular tachycardia (svt) with an intellanav st, they experienced unusually high temperature readings with very low power settings during every ablation.The power was started at 5-10 watts and titrated up to 30 watts.Temperature control mode was in use.No error messages occurred.They replaced the catheter with another of the same device, which worked appropriately, and the procedure was completed.No patient complications occurred and the "patient's outcome was favorable."the device is expected to be returned for analysis.
Additional Manufacturer Narrative
Upon receipt at our post market quality analysis laboratory the catheter was visually inspected, finding dried body fluid on the handle, shaft, and tip of the catheter.Electrical continuity testing showed all electrodes, sensors, and thermistor resistances fell within accepted specifications.Next the catheter was examined with x-ray and put through functional testing, no abnormalities were found in either case.The catheter was then subjected to additional electrical testing to simulate ablations.In this testing the catheter's power, impedance, and temperature readings were within acceptable specifications and no errors occurred.The reported failure in this complaint could not be confirmed through analysis as the device passed all electrical and functional testing.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that during an ablation procedure to treat supraventricular tachycardia (svt) with an intellanav st, they experienced unusually high temperature readings with very low power settings during every ablation.The power was started at 5-10 watts and titrated up to 30 watts.Temperature control mode was in use.No error messages occurred.They replaced the catheter with another of the same device, which worked appropriately, and the procedure was completed.No patient complications occurred and the "patient's outcome was favorable." 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
• MDR Report Key: 11156730
• Report Number: 2134265-2021-00217
• Device Sequence Number: 2590206
• Product Code: LPB
• UDI-Device Identifier: 08714729963950
• UDI-Public: 08714729963950
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2021

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: 01/08/2021
• Device Model Number: 87069
• Device Catalogue Number: 87069
• Device Lot Number: 0021587796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2021
• Initial Date Received by Manufacturer: 12/14/2020
• Supplement Date Received by Manufacturer: 02/10/2021
• Initial Report FDA Received Date: 01/12/2021
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1