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

Model Number H965SCH647070

Device Problems Premature Activation (1484); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 05/25/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that stent inadvertent deployment occurred.An 8.0-21 carotid wallstent¿ was selected for use to treat the lesion.However, during preparation when the protective guidewire on the tip was removed, the stent deployed automatically.There were no patient complications reported and the patient's status was stable.

Manufacturer Narrative

  device evaluated by mfr.: the delivery system was returned with the stent fully deployed.The deployed stent was also returned for analysis.The device was returned with the packing mandrel still loaded partially through the device.A visual and tactile examination of the device identified the t-connector on the stainless steel tube was fully retracted towards the heart shaped hub.The black limit marker which allows for reconstrainment had been exceeded.No damage or any issues were noted with the steal tube or t- connector that could have contributed to the complaint incident.A visual and tactile examination identified no issues with the catheter that could have contributed to the complaint incident.A visual and microscopic investigation identified no issues with the stent cup, stent holder or tip that could have contributed to the complaint incident.A visual and microscopic investigation identified no issues with the stent that could have contributed to the complaint incident.No other issues were identified during the product analysis.The manufacturing batch record review confirmed that the device met all material, assembly and performance specifications.The investigation conclusion is handling damage as the complaint was caused by handling of the device or portion of the device without direct patient contact.(b)(4).

Event Description

It was reported that stent inadvertent deployment occurred.An 8.0-21 carotid wallstent was selected for use to treat the lesion.However, during preparation when the protective guidewire on the tip was removed, the stent deployed automatically.There were no patient complications reported and the patient's status was stable.

• 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: 7620816
• MDR Text Key: 111867267
• Report Number: 2134265-2018-05461
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• Reporter Country Code: CN
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/12/2021
• Device Model Number: H965SCH647070
• Device Catalogue Number: SCH-64707
• Device Lot Number: 21600224
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/31/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/28/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/11/2018
• 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