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

Model Number	M00570360
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906); Detachment of Device or Device Component (2907); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/25/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary fully covered rmv stent was to be implanted in the common bile duct to treat biliary stricture and stones during an endoscopic retrograde cholangiopancreatography (ercp) performed on (b)(6) 2024.During the procedure, the stent was unable to advance through the distal portion of the scope and it came apart inside the scope.The stent was removed with difficulty and another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.Note: a photo of the complaint device was provided, and it was observed that the stent was partially deployed, and the tip and the outer sheath were detached.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a0501 captures the reportable event of tip detached.

• 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: 19577579
• Report Number: 3005099803-2024-02961
• Device Sequence Number: 17129581
• Product Code: PNB
• UDI-Device Identifier: 08714729953173
• UDI-Public: 08714729953173
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 06/20/2024

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: 02/22/2026
• Device Model Number: M00570360
• Device Catalogue Number: 7036
• Device Lot Number: 0033489044
• 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: 05/28/2024
• Initial Report FDA Received Date: 06/20/2024
• Date Device Manufactured: 02/23/2024
• 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
• Patient Sex: Unknown