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 07/01/2022

Event Type  malfunction  

Event Description

It was reported that device packaging was unsealed.A 6.0-22 carotid wallstent was selected for use.However, it was noted that the package was not sealed.The sterile pouch was opened and the sterility of the device was compromised.The procedure was completed with another of the same device.There were no patent complications reported.

Event Description

It was reported that device packaging was unsealed.A 6.0-22 carotid wallstent was selected for use.However, it was noted that the package was not sealed.The sterile pouch was opened and the sterility of the device was compromised.The procedure was completed with another of the same device.There were no patent complications reported.It was further reported that the device hasn't been used to treat the patient.Due to the sterility of the device was compromised, the physician used this one as a sample to his student to show how to deploy it.All this was processed outside patient's body.

Manufacturer Narrative

Device evaluated by mfr.: carotid wallstent monorail 6.0-22 was received for analysis.The device was received removed from all of its packaging.The outer box carton was received with the blue tear tab seal and box opened.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 the tyvek pouch indicating that a seal was made.A visual 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 to have been deployed from the delivery system.The stent of the device was not returned and was reported to have been deployed outside of the patient as a demonstration.No issues were noted with the returned device.This concludes the product analysis.

• Brand Name: CAROTID WALLSTENT
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15117066
• MDR Text Key: 296863785
• Report Number: 2124215-2022-24824
• Device Sequence Number: 1
• Product Code: NIM
• 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: 07/27/2022
• 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: 0027607635
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2021
• 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: 65 YR
• Patient Sex: Male
• Patient Weight: 70 KG