MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS VASCULAR SD; CATHETER, BILIARY, DIAGNOSTIC

Model Number 20201

Device Problems Difficult to Insert (1316); Material Deformation (2976)

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

Event Date 01/28/2024

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The patient underwent a stent implantation on the stenosis located in the vertebral artery.A 4.0mmx19mmx150cm express vascular sd was selected for treatment but it was noted that the stent could not cross the long sheath.After the stent was withdrawn, it was found that there was kink mark.The device was replaced by another of the same model to complete the procedure.No complications reported, and patient status was stable.

Event Description

It was reported that stent damage occurred.The patient underwent a stent implantation on the stenosis located in the vertebral artery.A 4.0mmx19mmx150cm express vascular sd was selected for treatment but it was noted that the stent could not cross the long sheath.After the stent was withdrawn, it was found that there was kink mark.The device was replaced by another of the same model to complete the procedure.No complications reported, and patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: express sd stent was returned stuck inside an unknown sheath.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual and microscopic examination revealed no damages.The device is stuck inside of the unknown sheath.X-ray of the sheath shows that the whole device is still intact and the stent is still on the balloon.There does not appear to be any damages.The unknown sheath was measured with pin gauges and it appears to be a 4f sheath.Inspection of the remainder of the device presented no damage or irregularities.

• Brand Name: EXPRESS VASCULAR SD
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 18902089
• MDR Text Key: 337631644
• Report Number: 2124215-2024-14753
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: CH
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20201
• Device Catalogue Number: 20201
• Device Lot Number: 0028985754
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/29/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/04/2022
• 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: 70 YR
• Patient Weight: 68 KG