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

Model Number	M00570640
Medical Device Problem Codes	Difficult to Remove (1528); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was implanted in the bile duct to treat a 2cm malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the procedure, a non-bsc guidewire was used inside the duct and the user wanted to change it.However, the wire would not exit out of the stent system.It was also reported that the stent looked imperfect at the end of the retrieving loop.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: a wallflex biliary stent and the delivery system were returned for analysis.The stent was returned fully covered and undeployed.Visual inspection found that the inner shaft was misaligned with the outer sheath.The blue outer sheath was found distally smashed or damaged and bent.The guidewire was backloaded with resistance; however, it does not exit at the guidewire access sheath (gas) ramp as expected.Functional testing by actuating the delivery system (sliding the handle back along the stainless-steel tube) was performed without problems and no resistance was felt on the stent.Product analysis confirmed the reported event of device difficult to withdraw guidewire.The investigation concluded that this event was most likely due the misalignment between the inner shaft with the outer sheath.Hence, the guidewire does not exit at the guidewire access sheath (gas) ramp as expected during the procedure.Also, the observed damage on the outer sheath was most likely due to procedural factors such as lesion characteristics, handling of the device, and technique used by the physician.Furthermore, the investigation could not confirm the reported event of stent material deformation as no resistance was felt, and no problems were found on the stent after functional inspection.Based on the information available, the investigation selected 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 uncovered stent was implanted in the bile duct to treat a 2cm malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was not dilated and was not tortuous prior to stent placement.During the procedure, a non-bsc guidewire was used inside the duct and the user wanted to change it.However, the wire would not exit out of the stent system.It was also reported that the stent looked imperfect at the end of the retrieving loop.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.

• Brand Name: WALLFLEX? BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23214031
• Report Number: 3005099803-2025-04976
• Device Sequence Number: 8890716
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: (01)08714729756231(17)270623(10)36819121
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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,Followup
• Report Date (Section B): 12/02/2025

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 Model Number: M00570640
• Device Catalogue Number: M00570640
• Device Lot Number: 0036819121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2025
• Supplement Date Received by Manufacturer: 11/06/2025
• Initial Report FDA Received Date: 10/03/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/23/2025
• 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