MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT ENDOPROSTHESIS; CATHETER, BILIARY, DIAGNOSTIC

Model Number	26280
Medical Device Problem Codes	Positioning Failure (1158); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/29/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that stent fracture occurred.A 20x80/10fr uni plus 75cm wallstent endoprosthesis was advanced for use.However, during deployment, the stent would not deploy and it was noted that the stent struts were fractured.The procedure was completed with another stent.There were no patient complications reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: the device was received with the stent in the correct position on the device.The stent deployed without resistance or issue experienced.The distal stent wires of the deployed stent were noted to be damaged.This type of damage is consistent with the stent encountering resistance during deployment.No other issues were noted with the stent.A visual and microscopic examination identified no damage or issues with the delivery system or shaft or tip of the device that could potentially have contributed to the complaint incident.Solidified media was noted on the tip of the device.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that stent fracture occurred.A 20x80/10fr uni plus 75cm wallstent endoprosthesis was advanced for use.However, during deployment, the stent would not deploy and it was noted that the stent struts were fractured.The procedure was completed with another stent.There were no patient complications reported and the patient was fine.

• Brand Name: WALLSTENT ENDOPROSTHESIS
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 9711258
• Report Number: 2134265-2020-01521
• Device Sequence Number: 353561
• Product Code: JCT
• UDI-Device Identifier: 08714729204114
• UDI-Public: 08714729204114
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K152842
• 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): 03/23/2020

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: 07/02/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024051074
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Initial Date Received by Manufacturer: 01/29/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 02/14/2020
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1