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

Model Number	87045
Medical Device Problem Codes	Failure to Deliver Energy (1211); Power Conditioning Problem (1474); Temperature Problem (3022)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for analysis.The distal end was bent curved to the left.The butt bond seal was cracked with rust color found in the gap between proximal and distal ends.The crack was located on the outer radius of the bent curve.Dried body fluid was found on the handle, main body tubing, distal end.Dried saline was on the distal end and inside several irrigation ports.While manipulating the shaft, continuity checks revealed no electrical opens or shorts as checked manually using a multi-meter and breakout box.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.X-ray found a broken steering wire solder joint and dried fluid debris inside the distal end cavity.
Event or Problem Description
Reportable based on device analysis completed on 03oct2019.It was reported that noise and high temperature errors prevented ablation.During a percutaneous catheter myocardial ablation procedure to treat atrial tachycardia, energization suddenly stopped as the intellanav open-irrigated catheter reached the temperature limit when the left atrium was being ablated.A subsequent high temperature error message appeared on the maestro generator.After resolving the error, the physician attempted to continue ablation, but severe noise appeared on the distal electrode upon energization.The temperature limit was once again reached, and ablation was halted as the error message reappeared.The cable was replaced, but the issue did not resolve.The catheter was replaced, and the issue was resolved.The procedure was successfully completed with the new catheter, and no serious injury or adverse patient effects occurred.Device analysis revealed evidence of fluid ingress through a cracked 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: 9245897
• Report Number: 2134265-2019-13078
• Device Sequence Number: 10865127
• 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): 10/28/2019

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: 05/20/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023827713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/03/2019
• Initial Report FDA Received Date: 10/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1