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

Model Number	26665
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a foreign material was found near the stent.A 8x29, 5f, 135cm carotid wallstent was selected for use to treat the lesion.After the device was flushed and removed the stylus, a piece of stylus or some sort of foreign material was found near the stent and another flushing was performed.The procedure was completed with another carotid wallstent.No patient complications were reported.
Event or Problem Description
It was reported that a foreign material was found near the stent.A 8x29, 5f, 135cm carotid wallstent was selected for use to treat the lesion.After the device was flushed and removed the stylus, a piece of stylus or some sort of foreign material was found near the stent and another flushing was performed.The procedure was completed with another carotid wallstent.No patient complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: carotid wallstent mr 8x29, 5f, 135cm was received for analysis.During the product analysis a bsc0.014" filterwire was advanced through this device without issue.No obstruction or foreign material (fm) was identified within the guidewire lumen.A visual and tactile examination identified a shaft kink 130mm proximal of the guidewire port.This type of damage is consistent with excessive force being applied to the device.The device was returned with the stent mounted fully constrained in the correct location on the device.The investigator successfully deployed the stent without issue.No damage or issues were noted with the deployed stent.The black stent holder of the device was clearly visible both before and after deployment of the stent.No fm was identified on or within the device before or post stent deployment.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; two scimed place; maple grove, MN 55311 ; 7634942574
• MDR Report Key: 13530154
• Report Number: 2134265-2022-00788
• Device Sequence Number: 11780500
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P050019
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/05/2022

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: 04/07/2025
• Device Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0028164055
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2022
• Supplement Date Received by Manufacturer: 03/14/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male