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

Model Number H965SCH647120

Device Problems Device Damaged Prior to Use (2284); Device Dislodged or Dislocated (2923)

Patient Problem No Patient Involvement (2645)

Event Date 09/20/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).(b)(4).

Event Description

It was reported that stent detachment occurred.A 10.0-24 carotid wallstent was selected for use.However, during preparation, when the guidewire was pulled out, the stent was detached from the delivery system.The procedure was completed using a new carotid wallstent.No complications were reported.

Manufacturer Narrative

Device evaluated by mfr: the complaint device was returned for analysis.The stent was returned in a vial.The stent was visually inspected and no issues were identified that may have contributed to the complaint.A visual and tactile inspection identified no issues along the length of the device.The guidewire used by the customer was still attached to the device.A visual and tactile inspection identified no issues with the stent holder.The stent impression was evident on the stent holder.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 stent detachment occurred.A 10.0-24 carotid wallstent was selected for use.However, during preparation, when the guidewire was pulled out, the stent was detached from the delivery system.The procedure was completed using a new carotid wallstent.No 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: 6033069
• MDR Text Key: 57567855
• Report Number: 2134265-2016-09073
• Device Sequence Number: 1
• Product Code: NIM
• Combination Product (y/n): N
• PMA/PMN Number: P050019
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/25/2020
• Device Model Number: H965SCH647120
• Device Catalogue Number: SCH-64712
• Device Lot Number: 0019642880
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/29/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/30/2016
• 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