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

Model Number	M00570540
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted in the bile duct to treat a cholangiocarcinoma during a procedure performed on (b)(6) 2022.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the wallflex biliary stent did not deploy inside the patient.The procedure was completed with another wallflex biliary stent.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.Note: this event has been deemed an mdr reportable event based on the investigation result which revealed the stent cover was damaged.
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx covered stent and delivery system were returned for analysis.The stent was received fully covered and undeployed.Visual examination was performed and found the outer sheath was stretched out in the guidewire access sleeve (gas) section.The inner shaft was not fully constrained and the tip is slightly pushed out of the outer sheath.Functional evaluation was performed and the stent was deployed with resistance.The stent cover was damage and the distal section of the device was found with residues of blood.No other issues with the stent and delivery system were noted.The reported even of stent failure to deploy was confirmed.The investigation concluded that the reported event and the observed failures were most likely due to procedural factors encountered during the procedure.It may be that the characteristics of the lesion, handling of the device during insertion of the guidewire, the techniques used by the user, limited the performance of the device and could have contribute to the damages noted in the outer sheath.Additionally, it is possible that the residues of blood found in the distal section of the device could have caused the resistance felt during the deployment of the stent.The scanning electron microscopy (sem) images identified the stent cover was damaged in the distal section.They may have occurred due to manipulation of the device; however, the investigation findings do not lead to a clear conclusion about the cause of the reported adverse event.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the directions for use (dfu) / product label.

• 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: 15543499
• Report Number: 3005099803-2022-05796
• Device Sequence Number: 15078628
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• 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
• Report Date (Section B): 10/05/2022

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: 09/08/2023
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0027984219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/14/2022
• Initial Report FDA Received Date: 10/05/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/08/2021
• 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: 62 YR
• Patient Sex: Male
• Patient Weight: 70 KG