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	06/05/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device eval by mfr.Distal end is bent in two places (s-curve) at approximately 30 and 52mm from the end of the tip.Dried body fluid was found on the handle, main body tubing, distal end and inside irrigation tubing and irrigation ports.All electrodes, thermocouple and sensor 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.X-ray found dried fluid inside of distal end.The device's lumen and distal end were leak tested using an isaac pressure decay test system.First, the irrigation holes and mes were sealed off with a touhy bourst seal.The lumen pressure decay was measured multiple times at 107 psi, with re-seating of the tb seal between each test.Pressure decay values were 0.6932, 0.5550 and 0.5180 psi (spec limit is 0.3 psi).Next, the distal end was inserted into fixture e181359-100 to seal the distal end.The distal shaft pressure decay was measured multiple times at 15 psi, with re-insertion of the distal end into the fixture between each test.Pressure decay values were 0.0267, 0.0180 and 0.0172 psi (spec limit is 0.044 psi).
Event or Problem Description
Complaint reportable based on analysis completed on 21aug2019.An intellanav open-irrigated catheter was selected for an atrial tachycardia (at) ablation procedure.The catheter was inserted inside the body, but then the temperature display became 65 degrees and energization could not be performed.The cable was replaced, but the issue was not resolved.The procedure was completed using another of the same catheter.No patient complications occurred.However, analysis revealed a leak in the cooling lumen allowed fluid ingress.

• 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: 9084260
• Report Number: 2134265-2019-11390
• Device Sequence Number: 11451198
• 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
• Report Date (Section B): 09/18/2019

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: 0023300596
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/21/2019
• Initial Report FDA Received Date: 09/18/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1