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

Model Number	H74938047830130
Medical Device Problem Codes	Premature Activation (1484); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	06/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination was performed on the returned device.The delivery system was returned for analysis.The stent was returned fully mounted onto the delivery system.A visual and microscopic examination was performed on the returned delivery system.No damage or any issues were noted with the catheter, tip or markerbands of the device.A visual and microscopic examination was performed on the balloon material.The proximal section of the balloon material was noted to be slightly inflated.The rest of the balloon was fully unfolded and had not been subjected to positive pressure.No issues were noted with the balloon material that could have contributed to the complaint incident.A visual and microscopic examination was performed on the stent.The proximal end of the stent was noted to be uncrimped from the balloon material.The balloon material below this section of uncrimped stent was noted to be slightly inflated.The rest of the stent was fully crimped to the balloon material.No damage or any issues were noted 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 or Problem Description
It was reported that stent premature deployment occurred.An 8.0x30x135cm express® ld iliac / biliary stent was selected for use to treat a lesion.However, during preparation, while the device was not yet attached to an inflation unit, it was noted that the stent was partially deployed on the balloon.The device was never used inside the patient.The procedure was completed with another of the same device.No patient complications were reported.

• Brand Name: EXPRESS® LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7660135
• Report Number: 2134265-2018-05827
• Device Sequence Number: 1980075
• Product Code: NIO
• UDI-Device Identifier: 08714729579700
• UDI-Public: 08714729579700
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P090003
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2018

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: 02/22/2020
• Device Model Number: H74938047830130
• Device Catalogue Number: 38047-83013
• Device Lot Number: 0020319304
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/19/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2018
• Initial Report FDA Received Date: 07/03/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1