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

Model Number	H965431000
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the suspect device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on february 3, 2020 that a wallstent biliary stent has been implanted to treat periampullary carcinoma in the common bile duct during a biliary stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure the stent migrated proximally immediately after deployment.The stent was not removed from the patient.The procedure was completed with a different device.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
Block h6: problem code 3009 captures the reportable event of stent positioning problem.Block h10: the returned hot axios delivery system was analyzed, and a visual evaluation noted that the stent was not returned.The outer blue sheath was returned kinked.A functional evaluation could not be performed because the stent was deployed.No other issues with the device were noted.The reported event of stent positioning issue could not be confirmed because this event occurred during procedure and it is not possible to replicate these events in the laboratory.It was confirmed that the outer blue sheath was kinked.Most likely, factors encountered during the procedure and/or the interaction with the scope could have caused the kink in the outer sheath and the patient's anatomy could have caused the stent positioning issue.The adverse event reported is known and documented in the labeling review; therefore, a review and analysis of all available information indicated that the most probable root cause is known inherent risk of device.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 that a wallstent biliary stent has been implanted to treat periampullary carcinoma in the common bile duct during a biliary stenting procedure performed on (b)(6), 2020.According to the complainant, during the procedure the stent migrated proximally immediately after deployment.The stent was not removed from the patient.The procedure was completed with a different device.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: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9763965
• Report Number: 3005099803-2020-00556
• Device Sequence Number: 504572
• Product Code: FGE
• UDI-Device Identifier: 08714729317920
• UDI-Public: 08714729317920
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2020

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: 05/29/2020
• Device Model Number: H965431000
• Device Catalogue Number: 43100
• Device Lot Number: 0022184206
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2020
• Initial Date Received by Manufacturer: 02/03/2020
• Supplement Date Received by Manufacturer: 03/24/2020
• Initial Report FDA Received Date: 02/27/2020
• Supplement Report FDA Received Date: 04/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1