MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RP ENDOPROSTHESIS; PROSTHESIS, TRACHEAL, EXPANDABLE

Model Number	26265
Medical Device Problem Code	Contamination (1120)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/08/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device contamination occurred.During preparation of an 8x40x135/ 6f reduced profile wallstent, the device became contaminated and lost sterility as it was being exchanged.The device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.
Event or Problem Description
It was reported that device contamination occurred.During preparation of an 8x40x135/ 6f reduced profile wallstent, the device became contaminated and lost sterility as it was being exchanged.The device never entered the patient's body.The procedure was completed with a different device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.The device was received with a 0.035inch wire inserted through the device.The guidewire was removed and measured.The outer diameter of the wire measured 0.035inch which is the recommended size wire for use with this device.A visual and tactile examination was performed on the returned wallstent device.No kinks or damage was identified along the surface of device.The deployment was handle was pushed to expose where the crimped stent should have been present.When the outer sheath retracted, it was identified that the stent had been deployed from the device and was not returned for analysis.An examination of the stent cup and stent holder identified no issues.No other issues were identified with the device.

• Brand Name: WALLSTENT RP ENDOPROSTHESIS
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8560640
• Report Number: 2134265-2019-04469
• Device Sequence Number: 2346506
• Product Code: JCT
• UDI-Device Identifier: 08714729406389
• UDI-Public: 08714729406389
• Combination Product (Y/N): N
• Initial Reporter State: RI
• 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,Followup
• Report Date (Section B): 06/05/2019

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: 01/07/2020
• Device Model Number: 26265
• Device Catalogue Number: 26265
• Device Lot Number: 0021578729
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2019
• Initial Date Received by Manufacturer: 04/10/2019
• Supplement Date Received by Manufacturer: 05/28/2019
• Initial Report FDA Received Date: 04/29/2019
• Supplement Report FDA Received Date: 06/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1