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 Consequences Or Impact To Patient (2199)
Date of Event	05/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
First date of the aware date month used as the event date, as no event date was reported.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.There were numerous shaft kinks.Microscopic examination of the device revealed that the stent was damaged 7mm from the proximal markerband.The tip was damaged.Inspection of the remainder of the device and stent presented no other damage or irregularities.
Event or Problem Description
Reportable based on device analysis completed on 02jul2019.It was reported that shaft kink occurred.A 6.0mmx18mmx150cm express sd renal/biliary stent was selected for use.However, it was noted that the device was kinked.No known patient complications were reported.However, returned device analysis revealed stent damage.

• 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: 8807927
• Report Number: 2134265-2019-08465
• Device Sequence Number: 13534887
• Product Code: NIN
• UDI-Device Identifier: 08714729484844
• UDI-Public: 08714729484844
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 07/19/2019

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: 12/19/2021
• Device Model Number: 20188
• Device Catalogue Number: 20188
• Device Lot Number: 0023109704
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/02/2019
• Initial Report FDA Received Date: 07/19/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1