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

Model Number 26605

Device Problem Difficult to Advance (2920)

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

Event Date 07/01/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address 1: (b)(6) hospital.E1: initial reporter phone: +(b)(6).A carotid device was received for analysis.A visual and tactile examination identified that there was a break in the outer sheath of the device approximately 170mm proximal from the distal tip.This carotid device is recommended for use with a guidewire as per carotid wallstent ifu.During product analysis the investigator was unable to load the device on to a boston scientific filter wire due to the outer sheath break.The device was returned with the stent fully mounted in the correct location on the device.

Event Description

Reportable based on device analysis completed on 21aug2023.It was reported that difficulty tracking the guidewire occurred.A 6.0-22 carotid wallstent was selected for used during a stent implantation procedure for a patient with super mesenteric artery stenosis.However, it was found that the guidewire could not cross the quick exchange hole after repeated attempts.The procedure was completed with a 7-30 stent.There were no patient complications reported.However, returned device analysis revealed a shaft break.

• Brand Name: CAROTID WALLSTENT
• Type of Device: 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: 17728732
• MDR Text Key: 323171027
• Report Number: 2124215-2023-45099
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 09/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0030503429
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/21/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/08/2022
• 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
• Patient Age: 68 YR
• Patient Sex: Male
• Patient Weight: 68 KG