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

Model Number	26280
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/10/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent was shorter than the labeled size.A 16x60/9fr uni plus 75cm wallstent-uni endoprosthesis self expanding stent was advanced for treatment.However, it was noted that the stent in the delivery system was shorter than it should be.The stent was not deployed and was pulled out of the patient.The procedure was completed with another of the same device.There were no patient complications nor injuries reported and the patient was fine.
Additional Manufacturer Narrative
Device evaluated by mfr.: a visual and tactile examination identified no issues with the tip of the device.The stent was returned fully constrained on the device.The stent was deployed without issue and a dried blood like substance was identified on the distal end of the stent indicating that it was partially deployed during the procedure.The stent length was measured and failed as the stent measured short.A visual and tactile examination of the shaft identified no issues.No other issues were identified during the product analysis.
Event or Problem Description
It was reported that the stent was shorter than the labeled size.A 16x60/9fr uni plus 75cm wallstent-uni endoprosthesis self expanding stent was advanced for treatment.However, it was noted that the stent in the delivery system was shorter than it should be.The stent was not deployed and was pulled out of the paitent.The procedure was completed with another of the same device.There were no patient complications nor injuries 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: 9642555
• Report Number: 2134265-2020-00648
• Device Sequence Number: 2474606
• Product Code: MAF
• UDI-Device Identifier: 08714729204046
• UDI-Public: 08714729204046
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 04/01/2020

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: 07/30/2021
• Device Model Number: 26280
• Device Catalogue Number: 26280
• Device Lot Number: 0024191867
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2020
• Initial Date Received by Manufacturer: 01/10/2020
• Supplement Date Received by Manufacturer: 03/23/2020
• Initial Report FDA Received Date: 01/29/2020
• Supplement Report FDA Received Date: 04/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1