MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION INTELLANAV OPEN-IRRIGATED; INTELLANAV OI

Model Number	87045
Medical Device Problem Code	Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/01/2019
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 the temperature reading remained constant during ablation.A intella nav oi was selected for a ablation procedure.When ablation was performed the temperature displayed remained unchanged at 51 degrees from the midway.Even if the catheter was taken out of the heart, the temperature did not change.There was no problem with the irrigation and there was no foreign object attached/adhered to the tip.It was suspected that the temperature sensor is defective.The procedure was completed using another catheter with no patient complications.
Event or Problem Description
It was reported the temperature reading remained constant during ablation.A intella nav oi was selected for a ablation procedure.When ablation was performed the temperature displayed remained unchanged at 51 degrees from the midway.Even if the catheter was taken out of the heart, the temperature did not change.There was no problem with the irrigation and there was no foreign object attached/adhered to the tip.It was suspected that the temperature sensor is defective.The procedure was completed using another catheter with no patient complications.
Additional Manufacturer Narrative
Device evaluated by mfr.Dried body fluid found on the handle, main body tubing and distal end.Dried saline on the distal end and inside several irrigation ports.All electrodes, sensor and thermocouple resistances measured in spec and were typical.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.Device was soaked for 30min during which it went through multiple ablation/agitation cycles.No temperature issues prior to, or during were observed.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Common Device Name: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• MDR Report Key: 8818270
• Report Number: 2134265-2019-08625
• Device Sequence Number: 16900962
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2019

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: 02/04/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023300816
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2019
• Initial Date Received by Manufacturer: 07/01/2019
• Supplement Date Received by Manufacturer: 09/04/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 10/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1