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

Model Number	H965431000
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary partially covered stent and delivery system were received for analysis.The stent was returned fully deployed.Visual examination of the returned device found the stent wire was loose.No other issues were noted to the stent and delivery system.The damage noted to the stent was most likely due to factors encountered during the procedure.It may be the interaction of the device with the scope, the technique used by the user and/or the patient tight anatomy, limited the performance of the device and could have caused resistance felt during the attempted stent deployment and caused the wire to become loose during the procedure.Therefore, a 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.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary partially covered stent was to be implanted to treat a 4-5 cm malignant stenosis in the common bile duct during a biliary stricture dilation procedure performed on april 19, 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent could not be deployed inside the patient.The stent was removed from the patient fully covered by the outer sheath and another wallstent biliary device was implanted 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.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent wires were loose.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11965878
• Report Number: 3005099803-2021-02723
• Device Sequence Number: 3172621
• Product Code: FGE
• UDI-Device Identifier: 08714729317920
• UDI-Public: 08714729317920
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/09/2021

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: 08/14/2022
• Device Model Number: H965431000
• Device Catalogue Number: 3100
• Device Lot Number: 0025860661
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/07/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2021
• Initial Report FDA Received Date: 06/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR