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

Model Number H965SCH647120

Device Problem Activation, Positioning or Separation Problem (2906)

Patient Problem No Patient Involvement (2645)

Event Date 12/14/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported that inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.No patient complications were reported and the patient's status was stable.

Manufacturer Narrative

Device evaluated by mfr.: the device was returned for analysis.The stent had already been deployed and was returned with the delivery device.A visual examination identified no issues with the stent or the stent holder.The stent impression was evident on the stent holder.A visual and tactile examination found no kinks or other damage along the length of the catheter.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 inadvertent stent deployment occurred.During unpacking of a 10.0-24 carotid wallstent¿, it was noted that the stent was detached from the stent delivery system.The procedure was completed with another of the same.No patient complications were 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: 7186869
• MDR Text Key: 97386990
• Report Number: 2134265-2017-13257
• 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: 12/20/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/15/2021
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 21133435
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/02/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/17/2017
• 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