MAUDE Adverse Event Report: BARD PERIPHERAL VASCULAR, INC. FLEXXUS® ENDOSCOPIC BILIARY STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	LXB10080
Health Effect - Clinical Code	Device Embedded In Tissue or Plaque (3165)
Date of Event	07/17/2018
Type of Reportable Event	Malfunction
Event or Problem Description
Flexxus endoscopic biliary stent placed in common bile duct by doctor using proper technique.Stent pulled down with rat tooth forceps and unexpectedly came apart in pieces.We grasped the duodenal end of stent and attempted to take out the stent with rat tooth forceps and snare but the end of the stent fell apart and so we ended up trimming the stent to the level of the papilla.We used a retrieval balloon to obtain a cholangiogram and all ducts appeared to fill with contrast, indicating patency.Final fluoroscopic views of the hemidiaphragm revealed no free air.The duodenoscope was then completely withdrawn, insufflated air was aspirated, and the patient was extubated and returned to the recovery area in good condition having tolerated the procedure well.The majority of the stent remains in patient.The pieces and original packaging were saved and will be given to company representative.No immediate post procedure complications were observed.

• Brand Name: FLEXXUS® ENDOSCOPIC BILIARY STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BARD PERIPHERAL VASCULAR, INC.; 1625 w. 3rd st.; tempe AZ 85281
• MDR Report Key: 7709835
• Report Number: 7709835
• Device Sequence Number: 1554828
• Product Code: FGE
• UDI-Device Identifier: 00801741099298
• UDI-Public: (01)00801741099298(11)170810(17)200725(10)ANBU2635
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/18/2018
• Report Date (Section F): 07/18/2018

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: LXB10080
• Device Catalogue Number: LXB10080
• Device Lot Number: ANBU2635
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 07/23/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Weight: 71
• Date Report Sent to FDA: 07/18/2018