MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565010
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	04/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
When deploying stent in duodenum, stent deployed too soon (before the point of no return).Due to stent deploying so soon it coiled on itself and did not deploy as intended.Stent was then hard to remove due to deploying incorrectly.
Event or Problem Description
When deploying stent in duodenum, stent deployed too soon (before the point of not return).Due to stent deploying so soon it coiled on itself and did not deploy as intended.Stent was then hard to remove due to deploying incorrectly.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14280109
• Report Number: 14280109
• Device Sequence Number: 17362030
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: (01)08714729456483(17)231122(10)28427439
• Combination Product (Y/N): N
• Initial Reporter State: IA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date (Section B): 04/20/2022
• Report Date (Section F): 04/20/2022

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 Model Number: M00565010
• Device Lot Number: 28427439
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 05/04/2022
• Supplement Report FDA Received Date: 05/04/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female
• Date Report Sent to FDA: 04/20/2022