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

Model Number 20201

Device Problem Premature Activation (1484)

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

Event Date 11/21/2022

Event Type  malfunction  

Event Description

It was reported that stent premature deployment occurred.A 5.0mmx15mmx150cm express vascular sd stent was selected for use.However, when unpacking the device and took out the stent delivery shaft, it was noticed that part of the stent was already deployed.The procedure was competed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

Manufacturer Narrative

Updated initial reporter's address and email.

Event Description

It was reported that stent premature deployment occurred.A 5.0mmx15mmx150cm express vascular sd stent was selected for use.However, when unpacking the device and took out the stent delivery shaft, it was noticed that part of the stent was already deployed.The procedure was competed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

Event Description

It was reported that stent premature deployment occurred.A 5.0mmx15mmx150cm express vascular sd stent was selected for use.However, when unpacking the device and took out the stent delivery shaft, it was noticed that part of the stent was already deployed.The procedure was competed with another of the same device.There were no patient complications nor injuries reported and the patient was stable.

Manufacturer Narrative

Device evaluated by mfr: returned product consisted of an express sd balloon catheter.The outer shaft, inner shaft, balloon and tip were visually and microscopically examined.Visual examination revealed that the stent is partially deployed.Microscopic examination revealed no damages.There is contrast present inside the inflation lumen.Inspection of the remainder of the device presented no damage or irregularities.Product analysis confirmed that the stent is partially deployed.

• Brand Name: EXPRESS VASCULAR SD
• Type of Device: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15941202
• MDR Text Key: 307912486
• Report Number: 2124215-2022-49348
• 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: Foreign,Health Professional,Company Representative,Distributor
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 02/13/2023

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: 20201
• Device Catalogue Number: 20201
• Device Lot Number: 0029010377
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/08/2022
• Supplement Dates Manufacturer Received: 12/27/2022; 01/26/2023
• Supplement Dates FDA Received: 01/18/2023; 02/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/09/2022
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 65 KG