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

Model Number 20201

Device Problems Difficult to Advance (2920); Material Deformation (2976)

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

Event Date 10/18/2023

Event Type  malfunction  

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in the opening of left vertebral.A 4.0mmx19mmx150cm express vascular sd stent was selected for use.However, upon delivery of the stent, the device could not be advanced into the long sheath.The stent was removed, and it was noted that the stent struts were deformed.The stent was replaced with another of the same device and was able to advance into the same long sheath.The stent was then deployed successfully.There were no patient complications reported, and the patient was stable post-procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 2: (b)(6).E1: initial reporter phone: (b)(6).

Event Description

It was reported that stent damage occurred.The 75% stenosed target lesion was located in the opening of left vertebral.A 4.0mmx19mmx150cm express vascular sd stent was selected for use.However, upon delivery of the stent, the device could not be advanced into the long sheath.The stent was removed, and it was noted that the stent struts were deformed.The stent was replaced with another of the same device and was able to advance into the same long sheath.The stent was then deployed successfully.There were no patient complications reported, and the patient was stable post-procedure.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 2: (b)(6).E1: initial reporter phone: (b)(6).Device evaluated by mfr.: returned product consisted of an express sd balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the distal end of the stent is damaged/flattened.Microscopic examination revealed no additional damages.Inspection of the remainder of the device presented no damage or irregularities.Product analysis found damage to the stent.

• 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: 18085801
• MDR Text Key: 327549399
• Report Number: 2124215-2023-60432
• 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,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2023
• 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: 0031247058
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/16/2023
• 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: 61 YR
• Patient Weight: 66 KG