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

Model Number 26606

Device Problems Obstruction of Flow (2423); Difficult to Advance (2920); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/21/2021

Event Type  malfunction  

Event Description

It was reported that foreign matter was present on the device.The target lesion was located in the severely tortuous internal carotid artery.An 8.0-29 carotid wallstent stent was selected for treatment.However, during preparation, the tail of the previously inserted 14 non- boston scientific guidewire did not come out of the monorail port of the wallstent.The preparation was restarted but did not solve the problem.Upon inspection of the monorail port of the stent, a foreign matter was stuck in it.The procedure was successfully completed with an 8x21 carotid wallstent.There were no patient complications nor injuries reported.

Manufacturer Narrative

Initial reporter name and address: (b)(6).

• Brand Name: CAROTID WALLSTENT
• Type of Device: 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: 12830473
• MDR Text Key: 280931705
• Report Number: 2134265-2021-14367
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/17/2021

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
• Device Operator: Health Professional
• Device Model Number: 26606
• Device Catalogue Number: 26606
• Device Lot Number: 0027805213
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2021
• Initial Date FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/09/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1