MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532910
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the stent was kinked at distal end and the proximal section of the stent was stretched and broken.Based on the product analysis, most likely some procedural/anatomical factors were encountered during the procedure which may have limited the overall performance of the device.A device under tortuous conditions due to patient anatomy or customer use/manipulation/maneuvering can lead to kink the stent at distal section, likely an additional device was used for retrieve the stent, this additional device could have contributed with the damages found on the device, probably the proximal section of the stent was grabbed with an additional device and it was pulled causing the device stretching, continued attempts to pull the stent resulted in stent breakage.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A dhr (device history record) review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ biliary stent was going to be use during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2018.According to the complainant, during the procedure, the stent kinked while it was inserted in the common bile duct.The procedure was completed with another advanix¿ 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 good.This event has been deemed a reportable event based on the investigation results; stent broken.

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7895348
• Report Number: 3005099803-2018-02596
• Device Sequence Number: 119033
• Product Code: FGE
• UDI-Device Identifier: 08714729786825
• UDI-Public: 08714729786825
• Combination Product (Y/N): N
• Initial Reporter Country: KR
• PMA/510(K) Number: K101314
• 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): 08/28/2018

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: 04/03/2020
• Device Model Number: M00532910
• Device Catalogue Number: 3291
• Device Lot Number: 21945415
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2018
• Initial Report FDA Received Date: 09/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 43 YR