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

Model Number M00565010

Device Problems Material Deformation (2976); Activation Problem (4042)

Patient Problem Insufficient Information (4580)

Event Date 04/08/2022

Event Type  malfunction  

Event 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 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
• Type of Device: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 14280109
• MDR Text Key: 290682567
• Report Number: 14280109
• Device Sequence Number: 1
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: (01)08714729456483(17)231122(10)28427439
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Date Report Sent to FDA: 04/20/2022
• Event Location: Hospital
• Date Report to Manufacturer: 05/04/2022
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/04/2022
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Female