MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number	26665
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent damage occurred.During unpacking of an 8x21, 5f, 135cm carotid wallstent, it was observed that there was a slight bent on the catheter at the portion where the stent was located.The device was never used and the procedure was completed with another of the same device.No patient complications were reported.
Event or Problem Description
It was reported that stent damage occurred.During unpacking of an 8x21, 5f, 135cm carotid wallstent, it was observed that there was a slight bent on the catheter at the portion where the stent was located.The device was never used and the procedure was completed with another of the same device.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was returned for analysis.A visual and tactile examination identified no issues with the catheter or delivery system that could potentially have contributed to the complaint incident.The device was returned with the stent fully mounted in the correct place on the delivery system.No issues were identified during the product analysis.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8841222
• Report Number: 2134265-2019-08845
• Device Sequence Number: 318441
• Product Code: NIM
• UDI-Device Identifier: 08714729781189
• UDI-Public: 08714729781189
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• 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): 08/27/2019

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: 10/22/2022
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0023680839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 08/13/2019
• Initial Report FDA Received Date: 07/30/2019
• Supplement Report FDA Received Date: 08/27/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1