MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS SD RENAL/BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	20188
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Event date populated as (b)(6) 2018 (first day of the month of the bsc aware date) as an actual event date was not reported.
Event or Problem Description
It was reported that premature deployment of stent occurred.A 7.0mmx19mmx90cm express sd renal/biliary stent was selected to treat the lesion.However, the device would not go through the sheath due to the leading end of the stent was partly opened.The device never entered the patient and it was replaced with another of the same device which deployed with no issue to successfully complete the case.No patient complications were reported and the patient did very well.

• Brand Name: EXPRESS SD RENAL/BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8092627
• Report Number: 2134265-2018-63017
• Device Sequence Number: 16505597
• Product Code: NIN
• UDI-Device Identifier: 08714729390527
• UDI-Public: 08714729390527
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K152607
• 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): 11/20/2018

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: 12/26/2020
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0021548197
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/01/2018
• Initial Report FDA Received Date: 11/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1