MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY EXPRESS® LD ILIAC / BILIARY; STENT, ILIAC

Model Number H74938047830130

Device Problems Bent (1059); Device Damaged Prior to Use (2284)

Patient Problem No Patient Involvement (2645)

Event Date 12/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received for analysis.A visual examination of the returned device confirmed that the balloon had not been subjected to positive pressure.No issues were noted with the balloon material.A visual and microscopic examination identified that on rows three to six of the distal stent struts, the struts were noted to have lifted.This type of damage is consistent with excessive force being applied to the device.No issues were noted with the tip of the device that could have potentially contributed to the complaint incident.A visual and tactile examination identified no issues with the shaft of the device that could have potentially contributed to the complaint incident.No other issues were identified during the product analysis.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 damage occurred.During preparation of an 8.0x30x135cm express® ld iliac / biliary stent, it was noted that the surface of the stent was uneven.The procedure was completed with another of the same device.No patient complications were reported and the patient's status was stable.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Type of Device: STENT, ILIAC
• 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: 7201489
• MDR Text Key: 97950256
• Report Number: 2134265-2017-13265
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: P090003
• 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
• Report Date: 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/14/2020
• Device Model Number: H74938047830130
• Device Catalogue Number: 38047-83013
• Device Lot Number: 0020406839
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/04/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/22/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/27/2017
• 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
• Patient Age: 55 YR