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

Model Number	M00569650
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	07/20/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter name and address: (b)(6).(b)(4).A wallstent biliary rx uncovered stent and delivery system were received for analysis.The stent was returned fully covered by the outer sheath and undeployed.Visual examination of the returned device found the wires of the stent punctured the outer sheath.The outer sheath was also kinked at the distal section.No other issues were noted to the stent.The reported event of stent failure to deploy was confirmed as the stent was received completely undeployed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that procedural or anatomical factors encountered during the procedure, limited the performance of the device and contributed to the stent deployment failure and the punctured outer sheath.Interaction with the scope during advancement and/or hitting the device against a hard surface can cause the outer sheath kinked.Continued attempts to release the stent while applying force can generate resistance due to the friction at the kinked section of the outer sheath, and force applied to deploy the stent can lead to the punctured sheath and failure to deploy the stent.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 rx uncovered stent was to be implanted to treat obstructive jaundice, secondary malignant tumors of the pancreas and liver and postoperative colon cancer in the biliary tract during a transduodenal endoscopic cholangiopancreatography procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the stent failed to deploy.The stent was removed from the patient fully covered by the outer sheath and the procedure was completed with another wallstent biliary stent.There were no patient complications 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 protruded from the outer sheath.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 12505878
• Report Number: 3005099803-2021-04916
• Device Sequence Number: 3289173
• Product Code: FGE
• UDI-Device Identifier: 08714729296850
• UDI-Public: 08714729296850
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 09/21/2021

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: 08/20/2022
• Device Model Number: M00569650
• Device Catalogue Number: 6965
• Device Lot Number: 0026836232
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/24/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/27/2021
• Initial Report FDA Received Date: 09/21/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 33 YR
• Patient Weight: 72