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

Model Number	M004R96200
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/31/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Reportable based on device analysis completed on december 14 2019.It was reported that inconsistent tracking occurred.During a atrial fibrillation ablation procedure with a intellanav oi catheter poor tracking was noted.The device would show up and then it would disappear consistently.The procedure was completed with another intellanav oi catheter.No patient complications were reported and the patient's current condition is fine.However, returned device analysis revealed fluid ingress.Visual inspection revealed that the distal end was bent.Dried body fluid was found on the handle, main body tubing, and distal end.Dried saline was found on the distal end and inside the irrigation ports.Electrical tests revealed no electrical shorts or opens.All electrodes, sensor, and thermocouple resistances measured in spec and were typical.Resistance and inductance measurements were intermittent and the magnetic sensor was not within specifications in the left curve configuration.No abnormal resistance was felt when actuating the steering mechanism.After removing the three ring electrodes, dried body fluid was found inside the ring 1 wire feed through hole.As the tubing was removed from the distal end, it was noted that it didn't seem well adhered to the base of the tip and was easily removed.After the tubing was removed, dried body/saline fluid was found surrounding the base of the tip.The magnetic sensor was electrically intermittent or open due to a broken sensor wire at the solder joint to the twisted wire pair.

• 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: 8232401
• Report Number: 2134265-2018-64951
• Device Sequence Number: 1624562
• Product Code: OAD
• UDI-Device Identifier: 08714729937432
• UDI-Public: 08714729937432
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: P150005/S005
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/09/2019

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: 04/05/2021
• Device Model Number: M004R96200
• Device Catalogue Number: 87045
• Device Lot Number: 0021957988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/01/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2018
• Initial Report FDA Received Date: 01/09/2019
• Patient Sequence Number: 1