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

Model Number	87045
Medical Device Problem Code	Data Problem (3196)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.Butt bond seal was damaged and body fluid is in the gap between proximal and distal sections.Dried body fluid found on the handle, main body tubing, distal end.Dried saline on the distal end and inside the irrigation ports.While manipulating the shaft, continuity checks revealed no electrical opens as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.However, r1, r2, r3, sensor 1, sensor 2, tc+ and tc- were shorted to tip.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.Noise testing in ablation condition met current device specifications, where peak to peak values were less than 0.4 mv.Maximum values of ~.11 mv peak to peak were observed in abl 1-2 bipole.No tracking issues observed during ablation.Device tested in all curve configurations, with numerous torqueing maneuvers.X-ray found fluid debris in the distal cavity between rings 1 & 3 and inside the tip.
Event or Problem Description
Reportable based on device analysis completed on 16aug2019.It was reported that the curve on the catheter would no longer deflect.During an ablation procedure for premature ventricular contractions, an intellanav open-irrigated catheter was selected for use.When the ablation was almost finished, the ablation catheter became unable to appear on the rhythmia.The cable was replaced, but it did not improve, so the ablation catheter was replaced, and it appeared on the rhythmia.The ablation procedure was completed without issue.No patient complications occurred.However, device analysis revealed the magnetic sensor was electrically shorted to the tip (gnd) due to the conductive nature of body fluid that entered the distal end cavity through a damaged butt bond seal.

• 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: 8992186
• Report Number: 2134265-2019-11013
• Device Sequence Number: 2867352
• 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): 09/11/2019

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: 0023297492
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/03/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2019
• Initial Report FDA Received Date: 09/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 54 YR