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

Model Number	M00570650
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a wallflex biliary rx uncovered stent was to be implanted in the common bile duct to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent failed to expand inside the patient after deployment.Consequently, the stent was removed using snares and the procedure was completed with another stent of a different model.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf impact code f2301 captures the reportable event of additional device required to remove the stent.Block h11: investigation results: based on the available information, boston scientific could not confirm the reported event of stent failure to expand.The stent was returned fully covered and undeployed and functional stent deployment testing was performed without resistance or problems.The investigation concluded that the additional observed events of distal tip and blue outer sheath bent were most likely caused by procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied).Device history record: it was confirmed this device met manufacturing specifications prior to distribution and there were no manufacturing deviations which could have contributed to the reported event.Device technical analysis: a wallflex biliary stent and delivery system was returned for analysis.Visual inspection found that the stent was fully covered and undeployed.Functional stent deployment testing, by actuating the delivery system (slide the handle back along the stainless-steel tube) was performed without resistance or problems.However, the distal tip and the blue outer sheath were found bent.No other damage was found on the returned stent.Risk review: a risk review was completed and confirmed that the reported events of stent failure to expand and additional device required were defined in the risk documentation.These event types have been accounted for during product risk analysis to support acceptable risk benefit for the product.Investigation conclusion: based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of no problem detected.
Event or Problem Description
It was reported that a wallflex biliary rx uncovered stent was to be implanted in the common bile duct to treat choledocholithiasis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent failed to expand inside the patient after deployment.Consequently, the stent was removed using snares and the procedure was completed with another stent of a different model.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: 23638990
• Report Number: 3005099803-2025-06251
• Device Sequence Number: 9258605
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: (01)08714729758150(17)260717(10)34451107
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K140630
• 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,Followup
• Report Date (Section B): 04/28/2026

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: 07/17/2026
• Device Model Number: M00570650
• Device Catalogue Number: M00570650
• Device Lot Number: 0034451107
• 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: 10/31/2025
• Supplement Date Received by Manufacturer: 04/05/2026
• Initial Report FDA Received Date: 11/24/2025
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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