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

Model Number	20232
Medical Device Problem Codes	Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that the stent was difficult to position and was removed.A wallflex biliary transhepatic stent was selected for use to treat pancreatic head conditional obstructive jaundice.Percutaneous access was achieved via a peripheral bile duct of the fifth segment.The wallflex biliary transhepatic stent was advanced to cover a section of biliary stenosis.However, the stent position was not optimal as it covered a bile duct.An unsuccessful attempt was made to recapture the stent using the distal loop, however, it was noted that the stent was damaged and had folded upon itself.A percutaneous transluminal angioplasty (pta) balloon was used to re-open the stent.An external-internal biliage drainage was placed through which the stent was removed.A new stent was placed and the procedure was successfully completed.There were no patient complications reported.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; two scimed place; maple grove MN 55311
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: jeff wallner ; 4100 hamline ave n; arden hills, MN 55112 ; 6515811560
• MDR Report Key: 16776263
• Report Number: 2124215-2023-16197
• Device Sequence Number: 20538158
• Product Code: FGE
• UDI-Device Identifier: 08714729799375
• UDI-Public: 08714729799375
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K112543
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2024
• Device Model Number: 20232
• Device Catalogue Number: 20232
• Device Lot Number: 0029336497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/28/2023
• Initial Report FDA Received Date: 04/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 63 YR
• Patient Sex: Unknown