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

Model Number	87045
Medical Device Problem Codes	Low impedance (2285); Impedance Problem (2950)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the effect of energization could not be observed.During a ablation procedure with a intellanav open-irrigated catheter, when energization was performed there was no loss of potential observed, and the impedance didn't decrease.The effect of energization cannot be observed.The catheter had an impedance range of 99 - 96 ohms.There was no error message confirmed.The procedure was approximately 1 hour after starting mapping when the issue occurred.After replacing the catheter with a non-bsc catheter, it was confirmed that there was a slight effect of energization, and that the impedance had dropped/decreased.The procedure was completed without issue.
Event or Problem Description
It was reported the effect of energization could not be observed.During a ablation procedure with a intellanav open-irrigated catheter, when energization was performed there was no loss of potential observed, and the impedance didn't decrease.The effect of energization cannot be observed.The catheter had an impedance range of 99 - 96 ohms.There was no error message confirmed.The procedure was approximately 1 hour after starting mapping when the issue occurred.After replacing the catheter with a non-bsc catheter, it was confirmed that there was a slight effect of energization, and that the impedance had dropped/decreased.The procedure was completed without issue.
Additional Manufacturer Narrative
The device was returned for analysis.Visual inspection revealed dried body fluid found on the handle, main body tubing, distal end.Dried saline on the distal end and inside several irrigation ports.Electrical tests revealed that 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.Functional inspection revealed 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.Hdx testing revealed a noise test was performed while observing impedance during ablation.Impedance measurements appeared normal and were typical.Noise testing during ablation condition met current device specifications, where peak to peak values were less than 0.4 mv.Maximum values of about 0.16 mv peak to peak were observed in the abl 1-2 bipole.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: 8818194
• Report Number: 2134265-2019-08632
• Device Sequence Number: 19634852
• 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): 09/23/2019

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: 05/07/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023759674
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: 07/04/2019
• Supplement Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MAESTRO 4000; MAESTRO 4000; MAESTRO 4000
• Patient Age: 81 YR