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

Model Number	87045
Medical Device Problem Codes	Improper Flow or Infusion (2954); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/03/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that inadequate irrigation occurred.A intellanav oi was selected for an ablation procedure.However it was noticed during preparation that the catheter's irrigation flow rate was low as observed by its looks.It flowed at low flow 2ml/min, but there were no water droplets came out.The physician judged that it was dangerous to use in this state, so the device was retrieved.The procedure was completed with no serious injury reported.
Additional Manufacturer Narrative
Visual inspection found that the distal end is twisted clockwise(cw) as viewed from the end of the distal tip.Dried saline was found on the distal end and inside several irrigation ports.A metriq pump and irrigation line was connected to the device.The distal end was suspended in the center of a glass beaker.The pump flow rate was set to 30 ml/min (ablation rate) for 5 minutes (150 ml expected).After 5 minutes, the beaker contained approximately 148 ml of saline, which was within spec.Test was repeated for right curve (149 ml) and left curve (148 ml), which were also in spec.The test was repeated with the flow rate set to 2 ml/min (standby rate) for 25 minutes (50 ml expected).After 25 minutes, the beaker contained approximately 49 ml of saline, which was within spec.Test was repeated for right curve (49.5 ml) and left curve (49.5 ml), which were also in spec.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.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.
Event or Problem Description
It was reported that inadequate irrigation occurred.A intellanav oi was selected for an ablation procedure.However it was noticed during preparation that the catheter's irrigation flow rate was low as observed by its looks.It flowed at low flow 2ml/min, but there were no water droplets came out.The physician judged that it was dangerous to use in this state, so the device was retrieved.The procedure was completed with no serious injury reported.

• 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: 8565129
• Report Number: 2134265-2019-04592
• Device Sequence Number: 2319567
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P150005
• 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): 07/16/2019

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: 11/16/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0022955840
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/03/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 04/30/2019
• Supplement Report FDA Received Date: 07/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1