MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY CAROTID WALLSTENT®; STENT, CAROTID

Model Number M001719040

Device Problems Device Damaged Prior to Use (2284); Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Date 06/15/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that the stent was missing.During preparation of a 10x24,5.9f,135cm carotid wallstent stent, when physician flushed the device, it was noted that there was no stent on the device.The device was not used inside the patient and the procedure was completed with a different device.No patient complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the investigator confirmed the stent was not on the device.The stent holder clearly displayed the stent imprint/impression.The stent imprint is performed which indicates that the stent was loaded onto the device.The stent holder clearly displayed the stent imprint/impression.A visual and tactile inspection identified no issues along the length of the delivery device.No issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The most probable root cause is considered handling damage as the event occurred without direct patient contact.(b)(4).

Event Description

It was reported that the stent was missing.During preparation of a 10x24,5.9f,135cm carotid wallstent® stent, when physician flushed the device, it was noted that there was no stent on the device.The device was not used inside the patient and the procedure was completed with a different device.No patient complications were reported.

• Brand Name: CAROTID WALLSTENT®
• Type of Device: STENT, CAROTID
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• Manufacturer (Section G): BOSTON SCIENTIFIC - GALWAY
• Manufacturer Contact: sonali arangil ; one scimed place; maple grove, MN 55311 ; 7634941700
• MDR Report Key: 6697280
• MDR Text Key: 79745590
• Report Number: 2134265-2017-06651
• Device Sequence Number: 1
• Product Code: NIM
• UDI-Device Identifier: 08714729781103
• UDI-Public: (01)08714729781103(17)20191025(10)0019182923
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 06/15/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/25/2019
• Device Model Number: M001719040
• Device Catalogue Number: 71-904
• Device Lot Number: 0019182923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/04/2016
• 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