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

Model Number 20212

Device Problems Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Perforation of Vessels (2135)

Event Date 08/24/2023

Event Type  Injury  

Event Description

It was reported that the tip of the balloon detached, requiring an additional device.This 10.0x30x75cm express ld vascular stent was selected for use in a vascular surgery.After deflation of the balloon, the tip with the balloon had remained in the introducer.It was noted that the wall of the artery was affected, requiring placement of another stent.No further patient complications were reported.

Event Description

It was reported that the tip of the balloon detached, requiring an additional device.This 10.0x30x75cm express ld vascular stent was selected for use in a vascular surgery.After deflation of the balloon, the tip with the balloon had remained in the introducer.It was noted that the wall of the artery was affected, requiring placement of another stent.No further patient complications were reported.It was further reported that the physician stated the allegation was against a non-boston scientific stent.The device has been returned and is undergoing analysis.

Event Description

It was reported that the tip of the balloon detached, requiring an additional device.This 10.0x30x75cm express ld vascular stent was selected for use in a vascular surgery.After deflation of the balloon, the tip with the balloon had remained in the introducer.It was noted that the wall of the artery was affected, requiring placement of another stent.No further patient complications were reported.It was further reported that the physician stated the allegation was against a non-boston scientific stent.The device has been returned and is undergoing analysis.

Manufacturer Narrative

Device eval by manufacturer: upon receipt at our post market quality assurance laboratory, this express ld vascular stent system was received with the balloon section detached and stuck inside the introducer sheath.The stent was not attached to the balloon section and was not received with the device.The introducer sheath was noted to be damaged and kinked.A visual and tactile examination of the shaft identified the shaft was detached 55mm proximal from the distal tip.A visual examination of the device identified no issues with the markerbands or tip.

• Brand Name: EXPRESS LD VASCULAR
• 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; ballybrit business park; galway ; EI
• Manufacturer Contact: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 17723972
• MDR Text Key: 323119413
• Report Number: 2124215-2023-49352
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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,Followup,Followup
• Report Date: 10/30/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0031274705
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/30/2023
• Initial Date FDA Received: 09/11/2023
• Supplement Dates Manufacturer Received: 09/18/2023; 10/16/2023
• Supplement Dates FDA Received: 10/12/2023; 10/30/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2023
• 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 Outcome(s): Required Intervention