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

Model Number 20201

Device Problems Contamination (1120); Unsealed Device Packaging (1444)

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

Event Date 08/15/2022

Event Type  malfunction  

Event Description

It was reported that device sterility was compromised.A 4.0mmx15mmx150cm express vascular stent was selected for use.However, it was noticed that the device package was not sealed, the sterile pouch was opened, and the device sterility was compromised.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

Device evaluated by mfr.: returned product consisted of an express sd balloon catheter inside the product pouch within the shelf box.The seal on the shelf box is open and the pouch inside are open.They appear to have been open by someone.Visual and microscopic examination of the device revealed no damages.There is blood present on the device.Inspection of the remainder of the device presented no damage or irregularities.Product analysis confirmed that the seals are open but it was likely done so by the user or someone at their facility.

Event Description

It was reported that device sterility was compromised.A 4.0mmx15mmx150cm express vascular stent was selected for use.However, it was noticed that the device package was not sealed, the sterile pouch was opened, and the device sterility was compromised.The procedure was completed with another of the same device.There were no patient complications reported and the patient status was stable.

• 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: 15392132
• MDR Text Key: 304007699
• Report Number: 2124215-2022-31647
• 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
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2022
• 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: 0028756372
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/27/2022
• 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: 72 YR
• Patient Sex: Female
• Patient Weight: 44 KG