MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CAROTID WALLSTENT; STENT, CAROTID

Model Number 26605

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

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

Event Date 08/18/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported that device seal and sterility were compromised.A 10.0-31 carotid monorail stent was selected for use in a percutaneous coronary intervention (pci).However, during unpacking, it was found that there was a visible tear or hole in the inner package and the sterility of the device was compromised.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

Manufacturer Narrative

E1- initial reporter facility name: (b)(6) medical college.Device evaluated by mfr.: a carotid wallstent monorail 10.0-31, was received for analysis.The device was received removed from all of its packaging.The outer box carton was received with a section from its distal end completely torn off.The detached section of the box carton was not received for analysis.The entire contents of the box carton had been removed.The inner packaging was identified to have its top seal opened.A visual examination identified no damage to the inner packaging other than it had been opened.A visual inspection confirmed a seal impression on both sides of the tyvek pouch indicating that a seal was made.A visual and microscopic examination identified that the seal of the protective tray had been opened.The carotid device had been removed from the tray.A visual examination identified no damage to the tray other than it had been opened.A visual inspection confirmed a seal impression indicating that a seal was made.A visual examination found the stent of the device in the correct position on the device.No issues or damage was noted with the returned device.No other issues were identified during analysis.

Event Description

It was reported that device seal and sterility were compromised.A 10.0-31 carotid monorail stent was selected for use in a percutaneous coronary intervention (pci).However, during unpacking, it was found that there was a visible tear or hole in the inner package and the sterility of the device was compromised.The procedure was completed with another of same device.There were no patient complications reported and the patient status was stable.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 12485027
• MDR Text Key: 271891285
• Report Number: 2134265-2021-11094
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 10/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 26605
• Device Catalogue Number: 26605
• Device Lot Number: 0027362986
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2021
• Date Manufacturer Received: 09/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 69