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

Model Number 20212

Device Problem Leak/Splash (1354)

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

Event Date 10/06/2023

Event Type  malfunction  

Manufacturer Narrative

E1 - initial reporter phone: (b)(6).Device evaluated by mfr.: express-vascular ld pmtd 8.0x40x135 cm was received for analysis.A visual examination found the stent to crimped in the correct position on the device.No damage or issues were noted with the stent.A visual examination identified the balloon had not been subjected to positive pressure and a pinhole the balloon material located approximately 3mm proximal of the proximal markerband was also noted.No other issues were noted with the balloon material.The rated burst pressure of this device is 12 atmospheres as per express ld specification.A visual examination identified no issues with the tip of the device.A visual and tactile examination identified no damage or any issues to the shaft of the device.

Event Description

Reportable based on device analysis completed on 15nov2023.It was reported that a shaft leak occurred.The greater than 70% stenosed target lesion was located in a non-tortuous and non-calcified subclavian artery.An 8.0x40x135 cm express ld vascular stent was advanced for treatment.However, during the procedure, the blood was leaking out via delivery sheath.The device was removed, and the procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.However, returned device analysis revealed balloon pinhole.

• 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: 18200074
• MDR Text Key: 328925090
• Report Number: 2124215-2023-66276
• 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
• Report Date: 11/23/2023

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: 0030601176
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/31/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/15/2023
• Initial Date FDA Received: 11/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/25/2022
• 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: 69 YR
• Patient Sex: Male
• Patient Weight: 70 KG