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

Model Number	20226
Medical Device Problem Codes	Break (1069); Difficult to Open or Remove Packaging Material (2922)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device evaluated by mfr.: an express ld device was returned for analysis.A visual examination of the returned device confirmed that the balloon was tightly wrapped and had not been subjected to positive pressure.No issues were noted with the balloon material.A visual examination found the stent positioned in the correct location on the balloon with no evidence of damage or any other issues noted.No issues were noted with the tip of the device.A visual and tactile examination identified a shaft break approximately 470mm from the distal end of the strain relief.The shaft was also noted to be severely stretched along the length of the device.The protective hoop was not returned with the device.
Event or Problem Description
Reportable based on device analysis completed on 05jul2022.It was reported that difficulty removal and shaft break occurred.An 8.0 x 40 x 135 cm express ld iliac / biliary stent was selected for use.However, during preparation, the stent was stuck in the packaging loop and shaft broke near the hub in the packaging loop with force on trying to dislodge.The procedure was completed.No patient complications were reported.However, returned device analysis revealed shaft break 470mm from the distal end of the strain relief.

• Brand Name: EXPRESS LD ILIAC / BILIARY
• Common Device Name: STENT, ILIAC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jay johnson ; 4100 hamline ave n; arden hills, MN 55112 ; 6515810888
• MDR Report Key: 15114698
• Report Number: 2134265-2022-07865
• Device Sequence Number: 14818965
• Product Code: NIO
• UDI-Device Identifier: 08714729392477
• UDI-Public: 08714729392477
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133110
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/27/2022

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: 06/25/2022
• Device Model Number: 20226
• Device Catalogue Number: 20226
• Device Lot Number: 0024013852
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/08/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/05/2022
• Initial Report FDA Received Date: 07/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/26/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown