MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	H965430500
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A fully constrained wallstent biliary uncovered stent and delivery system were received for analysis.Visual examination of the returned device found the stent and tip were pulled into the outer sheath.The stainless steel tube was kinked.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by cutting the outer sheath and pulling the inner member distally.Visual examination of the stent revealed that there were uncrossed and bent stent wires at one end.There were no other issues with the stent noted and no other issues with the delivery system were noted.The damages noted were consistent with the excessive force applied to the device.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be used to treat a 3cm malignant stenosis in the lower part of the bile duct during a stent placement procedure performed on (b)(6) 2018.According to the complainant, during procedure, the stent failed to deploy.Reportedly, several attempts were made to move the handle of the delivery system to start the deployment, but was unsuccessful.The stent was fully covered with the outer sheath when removed from the patient.The procedure was complete with another wallstent 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 investigation results which revealed uncrossed and bent stent wires at one end.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7731980
• Report Number: 3005099803-2018-02309
• Device Sequence Number: 2541540
• Product Code: FGE
• UDI-Device Identifier: 08714729204671
• UDI-Public: 08714729204671
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/08/2018

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: 04/12/2019
• Device Model Number: H965430500
• Device Catalogue Number: 43050
• Device Lot Number: 20519182
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/25/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/08/2018
• Initial Report FDA Received Date: 07/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1