MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY TRANSHEPATIC; CATHETER, BILIARY, DIAGNOSTIC

Model Number	20233
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent partially deployed and was removed without complete re-constrainment.The target location was located in the biliary tract.A 10mmx60mm wallflex biliary transhepatic stent was advanced through a 9fr sheath and deploy to the duodenum with a wire.During removal of delivery system from the sheath, it was noted that the stent was half deployed.The entire system was removed through the sheath and procedure was completed with another 10mmx60mm wallflex biliary transhepatic stent.No patient complications nor injuries were reported.
Event or Problem Description
It was reported that the stent partially deployed and was removed without complete reconstrainment.The target location was located in the biliary tract.A 10mmx60mm wallflex biliary transhepatic stent was advanced through a 9fr sheath and deploy to the duodenum with a wire.During removal of delivery system from the sheath, it was noted that the stent was half deployed.The entire system was removed through the sheath and procedure was completed with another 10mmx60mm wallflex biliary transhepatic stent.No patient complications nor injuries were reported.Device was returned with its original box.The stent was received deployed.A visual inspection identified no issues with the stent.A visual and tactile examination identified no issues with the stainless steel tube of the device.A visual and tactile examination found no damage or any issues with the inner member.A visual and tactile examination found severe kink at 9-inch approx from the valve body.A visual inspection identified no issues with the tip.The stent was measured in three sections (distal - medium - proximal) along the main body in order to confirm that is within specification.Inspected measurements results were found within specification.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• MDR Report Key: 7848054
• Report Number: 2134265-2018-60780
• Device Sequence Number: 1574260
• Product Code: FGE
• UDI-Device Identifier: 08714729820512
• UDI-Public: 08714729820512
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K112543
• 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): 10/15/2018

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 Expiration Date: 05/20/2020
• Device Model Number: 20233
• Device Catalogue Number: 20233
• Device Lot Number: 0022144407
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 09/05/2018
• Supplement Report FDA Received Date: 10/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1