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

Model Number 20212

Device Problems Failure to Advance (2524); Adverse Event Without Identified Device or Use Problem (2993)

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

Event Date 08/16/2023

Event Type  malfunction  

Event Description

Reportable based on device analysis completed on (b)(6) 2023.It was reported that crossing difficulties were encountered.The 70% stenosed target lesion was located in the severely tortuous and severely calcified superficial femoral artery.A 9.0x40x75cm express ld balloon catheter was advanced into the lesion but failed to cross.The procedure was completed with a different device.No patient complications were reported.However, returned device analysis revealed that the stent moved on the balloon.

Manufacturer Narrative

Device evaluated by mfr.Express-vascular ld was received for analysis.A visual examination identified that the stent had moved approximately 4mm proximally on the balloon catheter.A visual examination also found the stent struts to be damaged along the entire length.This type of damage is consistent with excessive force being applied to the device.No other issues were identified with the stent.A visual examination identified that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no damage or issues with the shaft of the device.

• 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: 18088030
• MDR Text Key: 328621922
• Report Number: 2124215-2023-59469
• Device Sequence Number: 1
• Product Code: FGE
• Combination Product (y/n): N
• Reporter Country Code: KS
• 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: 11/07/2023

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: 0031338007
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/04/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/07/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/30/2023
• 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: 66 YR
• Patient Sex: Male