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

Model Number	26280
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/07/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occured.A wallstent uni was selected for use for a venous compression case.After opening the package, the inner lining ripped down the middle and contaminated the device sterility.This occurred during preparation, while outside of the patient.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: 8378460
• Report Number: 2134265-2019-01784
• Device Sequence Number: 240363
• Product Code: JCT
• UDI-Device Identifier: 08714729204176
• UDI-Public: 08714729204176
• 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): 02/28/2019

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: 08/15/2020
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 22520374
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/08/2019
• Initial Report FDA Received Date: 02/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1