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

Model Number	20226
Medical Device Problem Codes	Device Contaminated During Manufacture or Shipping (2969); Packaging Problem (3007)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that device sterility was compromised.It was observed that an express ld iliac / biliary stent product box and device package was received damaged and the product pouch was compromised.The express stent was not used for a procedure.
Additional Manufacturer Narrative
Device evaluated by mfr: the device was returned for analysis.A visual and microscopic examination was performed on the returned packaging and device.The outer box carton was noted to be fully sealed and the blue tear tab was intact.A visual examination noted that the packaging was creased down the mid-section of the outer box carton.No issues were noted with the packaging that could have contributed to the damage identified.This damage is consistent with excessive force being applied to the packaging.The inner packaging was identified to be fully sealed.A visual examination identified no damage to the inner packaging.The outer and inner packaging were opened to allow for examination of the device.A visual and microscopic examination identified that the plastic protective tubing and express ld device were undamaged.No issues were noted with the device that could have contributed to the damage identified.No other issues were identified during analysis.
Event or Problem Description
It was reported that device sterility was compromised.It was observed that an express ld iliac / biliary stent product box and device package was received damaged and the product pouch was compromised.The express stent was not used for a procedure.

• 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: 9244391
• Report Number: 2134265-2019-13033
• Device Sequence Number: 448664
• Product Code: NIO
• UDI-Device Identifier: 08714729392316
• UDI-Public: 08714729392316
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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 Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024303683
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/08/2019
• Initial Date Received by Manufacturer: 10/04/2019
• Supplement Date Received by Manufacturer: 11/27/2019
• Initial Report FDA Received Date: 10/28/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1