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

Model Number	26665
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3 - date of event: date of event was approximated to 03/01/2024 as the exact event date was not reported.Device evaluated by mfr: the device was returned for evaluation.A visual and tactile examination identified no issues with the shaft of the device.The device was returned with the stent partially deployed by approximately 5mm.The stent was noted to be damaged.No other issues were identified during the product analysis.
Event or Problem Description
Reportable based on device analysis completed on 15apr2024.It was reported that the stent was defective.An 8x29, 5f, 135cm carotid wallstent was advanced for treatment.During the course of the procedure, it was noted that the stent was defective.There were no patient complications reported.However, device analysis revealed stent partial deployment and stent damage.

• Brand Name: CAROTID WALLSTENT
• Common Device Name: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 19277253
• Report Number: 2124215-2024-24198
• Device Sequence Number: 18036662
• Product Code: NIM
• UDI-Device Identifier: 08714729781202
• UDI-Public: 08714729781202
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/09/2024

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 Model Number: 26665
• Device Catalogue Number: 26665
• Device Lot Number: 0032701930
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2024
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/15/2024
• Initial Report FDA Received Date: 05/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/23/2023
• 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: Unknown