MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.A 18x90/10fr uni plus 75cm wallstent endoprosthesis was selected for use for a venous compression procedure.The stent was advanced over a.035 non-bsc guidewire.When the physician attempted to deploy the stent, the stent moved down significantly.An attempt to re-sheath the stent was made before the stent reached the second marker, but the stent buckled and was no longer the same length.The physician then removed the whole system from the body and saw that the distal end was kinked.Another 18x90/10fr uni plus 75cm wallstent endoprosthesis was selected for use, however, the same issue occurred.The procedure was completed with a larger stent and deployment was started higher, which was done successfully.There were no patient complications reported.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8390477
• Report Number: 2134265-2019-01983
• Device Sequence Number: 13820938
• Product Code: JCT
• UDI-Device Identifier: 08714729204084
• UDI-Public: 08714729204084
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• 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): 03/05/2019

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: 10/02/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 22743523
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2019
• Initial Report FDA Received Date: 03/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: GUIDE WIRE: CORDIS EMERALD J WIRE 035
• Patient Age: 64 YR