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

Model Number M004R96200

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/23/2018

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on 04sep2018.It was reported that magnetic tracking was lost during ablation.A intellanav oi ablation catheter was selected for use.During ablation, it was noted that there was no magnetic sensor in the catheter and it did not create a map.The procedure was completed with another of the same device.No patient complications were reported.However, analysis of returned product revealed saline and body fluid ingress through a split seal at the butt bond.Visual inspection was performed for intellanav oi ablation catheter.Distal end is bent at the butt bond and at 35mm from the end of the distal tip.Butt bond is split open around the entire circumference of the tubing.Body fluid ingress through the split in the butt bond.Dried body fluid also found on the handle, main body tubing and distal end.Dried saline found on distal end and inside the irrigation ports.Two locations of bent center support at the distal end, steering wire slack at the hub and separation at the butt bond.Continuity checks revealed no electrical shorts, as checked manually using a multi-meter and breakout box.All electrodes, sensor and thermocouple resistances measured in spec and were typical.The tension control knob functioned properly on both lock and unlock positions.The steering knob will not rotate more than a few degrees in either direction and the distal end will not curve.X-ray inspection found two locations of bent center support at the distal end, steering wire slack at the hub and separation at the butt bond.The distal end was dissected between the butt bond and the distal tip.The entire distal end cavity was filled with dried body fluid.The steering knob moved more freely now and able to rotate completely in both directions.Both distal end curves were misshapen due to the bent center support.The sensor resistance measurements ranged between 120-200 ohms in right and left curve which were out of spec.

• Brand Name: INTELLANAV OPEN-IRRIGATED
• Type of Device: INTELLANAV OI
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 4100 hamline avenue north; saint paul MN 55112
• Manufacturer (Section G): BOSTON SCIENTIFIC DE COSTA RICA S.R.L.; 302 parkway; global park la aurora; heredia ; CS
• Manufacturer Contact: timothy degroot ; 4100 hamline avenue north; dc a330; saint paul, MN 55112 ; 6515826168
• MDR Report Key: 7909739
• MDR Text Key: 122110371
• Report Number: 2134265-2018-61099
• Device Sequence Number: 1
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P150005/S005
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/11/2021
• Device Model Number: M004R96200
• Device Catalogue Number: 87045
• Device Lot Number: 0021850742
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/12/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 43 YR
• Patient Weight: 60