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

Model Number	H965430600
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallstent biliary uncovered stent was to be used to treat a malignant stricture in the hilar region of the common bile duct during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during stent deployment, the stainless steel hub suddenly twisted, and causing 80- 90% of the stent to be deployed outside the papilla.The stent was removed from the papilla with forceps and the procedure was completed 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.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallstent biliary uncovered stent was to be used to treat a malignant stricture in the (b)(6) of the common bile duct during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during stent deployment, the stainless steel hub suddenly twisted, and causing 80- 90% of the stent to be deployed outside the papilla.The stent was removed from the papilla with forceps and the procedure was completed 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.
Additional Manufacturer Narrative
A wallstent biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found that the stainless steel tube broken and kink.The clear exterior tube at the distal end and the inner member were found kinked.No other issues with the device were noted.The noted damages on the returned device were consistent with the excessive force being applied to the delivery system.The investigation concluded that procedural factors as the handling of the device and normal procedural difficulties encountered during the procedure could have possibly affected the device performance and its integrity contributing to the failure experienced by the customer.Therefore, the most probable root cause is operational context.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/product label.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.

• Brand Name: WALLSTENT¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7598096
• Report Number: 3005099803-2018-01916
• Device Sequence Number: 130741
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 05/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/03/2019
• Device Model Number: H965430600
• Device Catalogue Number: 43060
• Device Lot Number: 21336403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 10/17/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 11/08/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention