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

Model Number	20188
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/05/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was selected for use.However, before inserting the device into the patient's body, it was noticed that some stent struts appeared to be flared.The procedure was completed with a different device.There were no patient complications reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: returned product consisted of an express sd stented catheter.The balloon was loosely folded.The stent was secured between the markerbands.The hypotube, outer shaft, inner shaft, balloon, stent and tip were visually and microscopically examined.The stent is damaged in the middle of the stent.Inspection of the device presented no damage or irregularities.
Event or Problem Description
It was reported that stent damage occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was selected for use.However, before inserting the device into the patient's body, it was noticed that some stent struts appeared to be flared.The procedure was completed with a different device.There were no patient complications reported.

• 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: 9462259
• Report Number: 2134265-2019-15716
• Device Sequence Number: 2145942
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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,Followup
• Report Date (Section B): 01/31/2020

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: 10/07/2022
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0024559426
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2019
• Initial Date Received by Manufacturer: 12/05/2019
• Supplement Date Received by Manufacturer: 01/15/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 02/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1