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

Model Number 20226

Device Problem Unsealed Device Packaging (1444)

Patient Problem No Patient Involvement (2645)

Event Date 02/10/2019

Event Type  malfunction  

Event 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.

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 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
• Type of Device: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 8358514
• MDR Text Key: 136773327
• Report Number: 2134265-2019-01549
• Device Sequence Number: 1
• Product Code: NIO
• UDI-Device Identifier: 08714729392293
• UDI-Public: 08714729392293
• Combination Product (y/n): N
• PMA/PMN Number: K133110
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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 Manufacturer Received: 02/11/2019
• Initial Date FDA Received: 02/21/2019
• Supplement Dates Manufacturer Received: 04/04/2019
• Supplement Dates FDA Received: 04/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1