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

Model Number 20212

Device Problems Positioning Failure (1158); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 02/21/2024

Event Type  malfunction  

Manufacturer Narrative

E1 initial reporter facility name: (b)(6) hospital.E1 initial reporter address 1: (b)(6).

Event Description

It was reported that stent moved from balloon occurred.Vascular access was obtained via the right femoral artery.The target lesion was located in the subclavian artery.A 6f long sheath was placed, and a 260cm non-boston scientific guidewire was delivered in the lesion.A 5mmx40mm mustang balloon catheter was advanced for pre-dilation, then an 8.0x30x135cm express-vascular ld stent prepared and reached the lesion.During the procedure, the pressure was prepared for deployment.However, under digital subtraction angiography (dsa), the balloon expanded, but the stent slightly moves to the tip of the balloon but did not move out from the balloon.The pressure was removed and withdraw the device, it was confirmed the device could no longer be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

Event Description

It was reported that stent moved from balloon occurred.Vascular access was obtained via the right femoral artery.The target lesion was located in the subclavian artery.A 6f long sheath was placed, and a 260cm non-boston scientific guidewire was delivered in the lesion.A 5mmx40mm mustang balloon catheter was advanced for pre-dilation, then an 8.0x30x135cm express-vascular ld stent prepared and reached the lesion.During the procedure, the pressure was prepared for deployment.However, under digital subtraction angiography (dsa), the balloon expanded, but the stent slightly moves to the tip of the balloon but did not move out from the balloon.The pressure was removed and withdraw the device, it was confirmed the device could no longer be used.The procedure was completed with another of the same device.No complications were reported, and the patient was stable.

Manufacturer Narrative

E1: initial reporter facility name: (b)(6) hospital.E1: initial reporter address 1: (b)(6).Device evaluated by mfr.: visual examination identified that the stent had almost completely separated distally from the balloon catheter and was damaged along the entire length of the stent.Further examination identified that the balloon had been subjected to positive pressure indicating that stent deployment had been attempted.No issues were noted with the balloon material.A visual examination identified no issues with the tip or shaft of the device.The unreported stent damage noted during device analysis most likely occurred due to an interaction between the user and the device (unintended), at which stage of the procedure it occurred (during procedure/handling post procedure) cannot be established.

• 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: 18887163
• MDR Text Key: 337458106
• Report Number: 2124215-2024-14337
• 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: 05/02/2024

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: 20212
• Device Catalogue Number: 20212
• Device Lot Number: 0031714098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/12/2024
• Supplement Dates Manufacturer Received: 04/05/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/30/2023
• 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: 67 YR
• Patient Sex: Female
• Patient Weight: 60 KG