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

Model Number	M00570730
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/27/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered was used to treat secondary cholangitis due to biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the device was inserted into the working channel, and the stent deployment process was done; however, the stent could not be deployed, even after the device reached the point of no return.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.The procedure was not completed due to device availability.Subsequently, the procedure was rescheduled on (b)(6) 2024, using a different wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered was used to treat secondary cholangitis due to biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the device was inserted into the working channel, and the stent deployment process was done; however, the stent could not be deployed, even after the device reached the point of no return.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.The procedure was not completed due to device availability.Subsequently, the procedure was rescheduled on (b)(6) 2024, using a different wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.Additional information received on october 23, 2024: a photo of the device was provided showing the inner sheath kinking out of the guidewire access sheath (gas) section.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated with additional information received on october 23, 2024.Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered was used to treat secondary cholangitis due to biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the device was inserted into the working channel, and the stent deployment process was done; however, the stent could not be deployed, even after the device reached the point of no return.Reportedly, the stent was fully covered by the outer sheath when it was removed from the patient.The procedure was not completed due to device availability.Subsequently, the procedure was rescheduled on october 01, 2024, using a different wallflex biliary stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.**additional information received on october 23, 2024** a photo of the device was provided showing the inner sheath kinking out of the guidewire access sheath (gas) section.
Additional Manufacturer Narrative
Block h6: imdrf impact code f1001 is being used to capture the reportable event of aborted/cancelled procedure.Block h11: a wallflex biliary stent and delivery system were received for analysis.Visual inspection found that the inner sheath was kinking out of the guidewire access sleeve (gas) section and the outer sheath was returned stretched out in the gas section.The gas ramp was returned lifted.No other problems were noted with the device.Product analysis confirmed the reported events of stent failure to deploy and inner shaft/sheath kinking out of gas.The investigation concluded that the reported events additional observed event of sheath damaged were most likely due to procedural factors such as lesion characteristics, handling of the device, and the technique used by the physician.Therefore, taking all available information into consideration, the overall root cause of the reported event is adverse event related to procedure.

• 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: 20588825
• Report Number: 3005099803-2024-05478
• Device Sequence Number: 6558361
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: (01)08714729759324(17)250709(10)31977687
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• 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): 06/03/2025

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 Expiration Date: 07/09/2025
• Device Model Number: M00570730
• Device Catalogue Number: M00570730
• Device Lot Number: 0031977687
• 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: 10/08/2024
• Supplement Date Received by Manufacturer: 10/23/2024; 05/06/2025
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 11/18/2024; 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/10/2023
• 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 Age: 83 YR
• Patient Sex: Male