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

Model Number	M00570380
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Device-Device Incompatibility (2919); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable investigation finding of inner sheath detachment.Block h10: the wallflex biliary rx fully covered rmv stent delivery system was returned for analysis.The stent was not received for analysis.Visual inspection found that the inner sheath was detached, and the outer sheath was kinked.No other damages were noted with the delivery system.Product analysis did not confirm the reported events because the stent was not returned for analysis so the event of stent partial deployment could not be confirmed.Additionally, the reported event of device interaction with another device cannot be confirmed because this occurred during the procedure, and it was not possible to replicate in the laboratory of analysis.However, the additional investigation findings of inner sheath detachment and outer sheath kinking were found to be most likely due to procedural factors such as lesion characteristics, the handling of the device, and the technique used by the physician (force applied), which could have resulted in the damages noted in the device.Therefore, a review and analysis of all available information indicated that the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx fully covered rmv stent was to be implanted in the common hepatic duct to treat a 1-2 mm diameter x 2 cm length indeterminate stricture due to primary sclerosing cholangitis during an endoscopic retrograde cholangiopancreatography (ercp) with fully covered stent placement performed on (b)(6) 2024.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the guidewire sheath detached, which would not allow the stent to be fully deployed.The partially deployed stent and the guidewire were removed from the patient, and the procedure was completed with a different stent.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation finding of inner sheath detachment or separation.Please see block h10 for the full investigation details.

• 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: 18735625
• Report Number: 3005099803-2024-00585
• Device Sequence Number: 14888273
• Product Code: PNB
• UDI-Device Identifier: 08714729953197
• UDI-Public: 08714729953197
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/19/2024

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: 07/13/2025
• Device Model Number: M00570380
• Device Catalogue Number: 56424
• Device Lot Number: 0032019202
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/10/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/30/2024
• Initial Report FDA Received Date: 02/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/14/2023
• 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: Female