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

Model Number	H74938047830130
Medical Device Problem Codes	Bent (1059); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	12/20/2017
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7201489
• Report Number: 2134265-2017-13265
• Device Sequence Number: 13713978
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/22/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2017
• Initial Report FDA Received Date: 01/17/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR