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

Model Number	M00570630
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block e1: initial reporter facility name: the third affiliated hospital of pla navy medical university of chinese people's liberation army; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was used to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed; however, the stent was found to be broken.The stent was removed using a snare, and the procedure was completed using another of the same device.No patient complications were reported due to this event and the patient condition after the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was used to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6).2024.During the procedure, the stent was deployed; however, the stent was found to be broken.The stent was removed using a snare, and the procedure was completed using another of the same device.No patient complications were reported due to this event and the patient condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter facility name: (b)(6).Block h6: imdrf device code a0401 captures the reportable event of stent break.Block h11: a wallfex biliary stent was received for analysis.The stent was returned fully covered and undeployed.Additionally, the stent was inspected, and no damages were noted.A functional test was performed by actuating the delivery system (sliding back the handle along the stainless-steel tube) without problems and there was no resistance felt.No other problems were noted with the stent and delivery system.Product analysis was unable to confirm the reported event of stent break and additional device required.Upon inspection, the device was found fully covered and undeployed.After deployment and further inspection, no damages were detected.Therefore, a review and analysis of all available information indicated that the most probable cause is no problem detected.
Additional Manufacturer Narrative
Blocks b5 and h11 were corrected.Block e1: initial reporter facility name: the third affiliated hospital of (b)(6) medical university of chinese people's liberation army; reported here as this exceeded character limit for the designated field.Block h6: imdrf device code a0401 captures the reportable event of stent break.Imdrf device code a15 captures the reportable event of stent partially deployed.Block h11: a wallfex biliary stent and delivery system were received for analysis.The stent was returned fully covered and undeployed.Additionally, the stent was inspected, and no damages were noted.A functional test was performed by actuating the delivery system (sliding back the handle along the stainless-steel tube) without problems and there was no resistance felt.No other problems were noted with the stent and delivery system.Product analysis was unable to confirm the reported event of stent partially deployed and stent break.Based on the available information, there is not enough information to confirm the reported events; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was used to treat a bile duct stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was attempted to be deployed; however, the stent was found broken.The stent was removed, and the procedure was completed using another of the same device.No patient complications were reported due to this event and the patient condition after the procedure was reported to be stable.A photo of the complaint device was provided, and the stent was partially deployed with the stent wire was broken.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 20979207
• Report Number: 3005099803-2024-06515
• Device Sequence Number: 15568923
• Product Code: FGE
• UDI-Device Identifier: 08714729759270
• UDI-Public: 08714729759270
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2025

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: 05/24/2025
• Device Model Number: M00570630
• Device Catalogue Number: M00570630
• Device Lot Number: 0031689775
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/22/2024
• Supplement Date Received by Manufacturer: 01/02/2025; 01/30/2025
• Initial Report FDA Received Date: 12/19/2024
• Supplement Report FDA Received Date: 01/22/2025; 02/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/25/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 62 YR
• Patient Sex: Female
• Patient Weight: 60 KG