MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXPRESS LD ILIAC / BILIARY; STENT, ILIAC

Model Number	20226
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/10/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that unsealed device packing was encountered.During preparation of a 8.0x60x75cm express ld iliac / biliary stent, it was noted that the inner pouch was not completely sealed.There was no visible hole or tear in the pouch.The device was not used inside the patient and the procedure was completed with different device.No patient complications nor injuries were reported.
Additional Manufacturer Narrative
Device evaluated by mfr: a visual and microscopic examination was performed on the returned packaging and delivery system.The device was returned with the stent fully mounted onto the delivery system.One severe kink was noted on the shaft of the delivery system approximately 360mm distal to the strain relief.This type of damage is consistent with excessive force being applied to the delivery system.No damage was noted to the balloon, tip, crimped stent or markerbands.No issues were noted with the delivery system or stent that could have contributed to the complaint incident.The tab was noted to be open on the outer box carton.No issues were noted with the opening tab or box carton that could have contributed to the complaint incident.The inner foil packaging was returned opened.One side of the packaging and the top was noted to be opened, the remainder of the packaging was still sealed.The heat seal was visible on the opened packaging of the device which demonstrates the package was sealed during manufacturing.There was no gap in the seal.No issues were noted with the foil packaging that could have contributed to the complaint incident.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that unsealed device packing was encountered.During preparation of a 8.0x60x75cm express ld iliac / biliary stent, it was noted that the inner pouch was not completely sealed.There was no visible hole or tear in the pouch.The device was not used inside the patient and the procedure was completed with different device.No patient complications nor injuries were reported.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8358514
• Report Number: 2134265-2019-01549
• Device Sequence Number: 139654
• Product Code: NIO
• UDI-Device Identifier: 08714729392293
• UDI-Public: 08714729392293
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2019

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: 05/13/2021
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 22113374
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 02/21/2019
• Supplement Report FDA Received Date: 04/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1