MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570370
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/26/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of inner sheath detached.Imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf code f2301 captures the additional device used to remove the broken piece of the inner sheath.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was implanted in the bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was tight.During the procedure, the stent was successfully deployed.The physician attempted to resheath the catheter before removing it from the scope, but the catheter became stuck in the scope.The physician ultimately had to yank on the catheter, which caused the inner sheath to break inside the patient's stomach.A rescue forceps was used to remove the broken piece.The stent remains implanted, and the procedure was completed.No patient complications were reported as a result of this event.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 20538112
• Report Number: 3005099803-2024-05387
• Device Sequence Number: 6697311
• Product Code: PNB
• UDI-Device Identifier: 08714729953180
• UDI-Public: 08714729953180
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/25/2024

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: 07/14/2026
• Device Model Number: M00570370
• Device Catalogue Number: 7037
• Device Lot Number: 0034426517
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2024
• Initial Report FDA Received Date: 10/25/2024
• Date Device Manufactured: 07/14/2024
• 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 Sex: Unknown