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

Model Number	H965430500
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/27/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be used in the biliary duct to treat a malignant stenosis during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the wallstent biliary stent would not deploy.The wallstent biliary stent was removed from the patient fully covered by the outer sheath and the procedure was completed with another wallstent biliary device.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the two stent wires punctured the outer sheath.
Additional Manufacturer Narrative
Initial reporter's city and state/province: (b)(6).(b)(4).A wallstent biliary uncovered stent and delivery system were returned for analysis.The stent was received undeployed and was fully covered by the outer sheath.Visual examination found two wires of the stent were returned puncturing the outer sheath.Additionally, the outer blue sheath was returned detached from the valve body.No other damages with the stent and delivery system were noted.The reported event of stent failure to deploy was confirmed; the stent was received fully covered and undeployed.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 interaction of the device with the scope, the patient's anatomy and the excessive force applied to the device when the physician tried to deploy the stent, limited the performance of the device.Therefore, contributing to the detachment of the outer blue sheath from the valve body (handle), stent wires puncturing the outer sheath and stent deployment failure.Therefore, review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: WALLSTENT 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: 15221088
• Report Number: 3005099803-2022-04533
• Device Sequence Number: 17614059
• Product Code: JCT
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K982184
• 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
• Report Date (Section B): 08/12/2022

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: 01/06/2024
• Device Model Number: H965430500
• Device Catalogue Number: 3050
• Device Lot Number: 0028636590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/27/2022
• Initial Report FDA Received Date: 08/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2022
• 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 Sex: Unknown