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

Model Number 20212

Device Problems Difficult to Insert (1316); Difficult to Remove (1528)

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

Event Date 01/25/2024

Event Type  malfunction  

Event Description

It was reported that removal difficulties were encountered.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified left subclavian artery.Following pre-dilatation, an 8.0x40x135 cm express ld vascular stent was advanced but could not be inserted into the sheath.The stent was eventually deployed; however, the balloon could not be withdrawn smoothly.The device was removed after repeated inflation and deflation of the balloon for nearly 50 minutes.The procedure was completed with this device.No patient complications nor injuries were reported.

Manufacturer Narrative

The express ld vascular was returned for analysis without the customer's sheath.During analysis the investigator successfully advanced and withdrew the device through a boston scientific 6fr sheath without any resistance or issues noted.A visual examination of the returned device confirmed that the balloon had been subjected to positive pressure and the stent deployed from the balloon catheter.No issues were noted with the balloon material.The stent was not returned for analysis as it was reported to have been deployed inside the patient.No issues were noted with the tip of the device.A visual and tactile examination identified no kinks or issues with the shaft of the device.

Event Description

It was reported that removal difficulties were encountered.The 99% stenosed target lesion was located in the moderately tortuous and mildly calcified left subclavian artery.Following pre-dilatation, an 8.0x40x135 cm express ld vascular stent was advanced but could not be inserted into the sheath.The stent was eventually deployed; however, the balloon could not be withdrawn smoothly.The device was removed after repeated inflation and deflation of the balloon for nearly 50 minutes.The procedure was completed with this device.No patient complications nor injuries were reported.

• 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: 18722618
• MDR Text Key: 336420299
• Report Number: 2124215-2024-08810
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• 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: 0032226384
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2023
• 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
• Treatment: GUIDEWIRE: RADIFOCUS; GUIDEWIRE: RADIFOCUS; INTRODUCER SHEATH: (B)(6) ; INTRODUCER SHEATH: (B)(6)