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

Model Number	87045
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned with no allegation against it.Analysis found the device was missing a luer fitting from the end of the irrigation tubing.Due to cyclic fatigue, the adhesive and irrigation tubing tore open at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.The tear caused the luer fitting to separate from the tubing.
Event or Problem Description
Reportable based on device analysis completed on 28jun2019.The device was returned without a complaint.Device analysis found the adhesive and irrigation tubing tore open at the proximal (narrowest) side of the adhesive joint securing the tubing to the luer fitting.The tear caused the luer fitting to separate from the tubing.

• 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: 8802846
• Report Number: 2134265-2019-08421
• Device Sequence Number: 16223339
• Product Code: OAD
• UDI-Device Identifier: 08714729937456
• UDI-Public: 08714729937456
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 07/18/2019

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: 06/06/2021
• Device Model Number: 87045
• Device Catalogue Number: 87045
• Device Lot Number: 0022220774
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2019
• Initial Report FDA Received Date: 07/18/2019
• Patient Sequence Number: 1