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

Model Number	87045
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient age: 18 years or older.
Event or Problem Description
It was reported that a catheter leak occurred.During an ablation procedure for uncommon atrial flutter, an intella nav oi catheter was selected for use.The catheter was inserted into the left atrium.Upon manipulation, water leaked from the area near the port that connects the saline for irrigation.No error messages displayed on the maestro generator.It was suspected that there was a hole in the tube part of the port.The procedure was completed successfully using a non-boston scientific (bsc) replacement device.No serious injury occurred to the patient.
Additional Manufacturer Narrative
Patient age: 18 years or older.The device was returned for analysis.The irrigation tubing was torn at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.Dried body fluid was found on the handle, main body tubing and distal end.Dried saline was found on the distal end and inside several irrigation ports.
Event or Problem Description
It was reported that a catheter leak occurred.During an ablation procedure for uncommon atrial flutter, an intella nav oi catheter was selected for use.The catheter was inserted into the left atrium.Upon manipulation, water leaked from the area near the port that connects the saline for irrigation.No error messages displayed on the maestro generator.It was suspected that there was a hole in the tube part of the port.The procedure was completed successfully using a non-boston scientific (bsc) replacement device.No serious injury occurred to the patient.

• 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: 8654398
• Report Number: 2134265-2019-06091
• Device Sequence Number: 11324536
• 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): 07/17/2019

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: 02/04/2022
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0023297030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2019
• Initial Date Received by Manufacturer: 05/09/2019
• Supplement Date Received by Manufacturer: 06/21/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 07/17/2019
• Patient Sequence Number: 1