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

Model Number	M00570530
Medical Device Problem Codes	Material Deformation (2976); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary covered stent was to be implanted in the bile duct to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to fully expand.Consequently, the stent's position was adjusted but it was stuck and could not be moved.The stent was removed with a foreign body forceps and another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Imdrf device code a150101 captures the reportable event of stent failure to expand.: a wallflex biliary covered stent and delivery system were received for analysis.The stent was fully deployed and expanded.Visual inspection found the outer sheath kinked.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent failure to expand.It is possible that the observed event of outer sheath kinked was due to procedural factors such as an excess force or the manner the device was handle and manipulated.Excessive manipulation of the device without enough care could have likely caused the observed event.There is no indication of the reported event of stent failure to expand because the stent was received fully deployed and expanded.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 covered stent was to be implanted in the bile duct to treat a malignant stricture during a stent placement procedure performed on (b)(6) 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to fully expand.Consequently, the stent's position was adjusted but it was stuck and could not be moved.The stent was removed with a foreign body forceps and another wallflex biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 19155297
• Report Number: 3005099803-2024-01788
• Device Sequence Number: 15287628
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• 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
• Report Date (Section B): 07/02/2024

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: 02/27/2025
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0031136034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/02/2024
• Supplement Date Received by Manufacturer: 06/06/2024
• Initial Report FDA Received Date: 04/22/2024
• Supplement Report FDA Received Date: 07/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/28/2023
• 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: 45 YR
• Patient Sex: Male
• Patient Weight: 78 KG