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

Model Number 20188

Device Problem Premature Activation (1484)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/01/2018

Event Type  malfunction  

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 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
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC SCIMED, INC; two scimed place; maple grove MN 55311
• Manufacturer Contact: sonali arangil ; two scimed place; maple grove, MN 55311 ; 6515827403
• MDR Report Key: 8092627
• MDR Text Key: 128031275
• Report Number: 2134265-2018-63017
• Device Sequence Number: 1
• Product Code: NIN
• UDI-Device Identifier: 08714729390527
• UDI-Public: 08714729390527
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152607
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/01/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/27/2017
• 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