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

Model Number	M00534270
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the device was performed.The reported event was not confirmed, the stent was returned unloaded from the delivery system, therefore the alleged issue could not be confirmed.It was observed that the stent was damaged in several locations, showing excess of handling/manipulation.Also the stent was bent and the suture hole was slightly torn.The investigation concluded that the device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering can cause difficulty to deploy the stent, continued efforts to deploy the stent can cause damages the stent.It is most likely that anatomical or procedural factors encountered during the procedure could have contributed with the reported failures, therefore operational context is selected as the most probable root cause for the complaint event.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in common bile duct on (b)(6) 2016.According to the complainant, while the physician was placing the advanix biliary stent in the patient¿s common bile duct, the endoscopic marker on the distal end of the stent was not visible, so the physician removed the stent from the patient.Upon examination of the stent, the physician reported that the endoscopic marker appeared to be on the proximal end of the stent and not the distal end of the stent.The device was not implanted and 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".This event has been deemed a reportable event based on the investigation results; stent kinked.

• 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: 6216019
• Report Number: 3005099803-2016-04005
• Device Sequence Number: 408066
• Product Code: FGE
• UDI-Device Identifier: 08714729787365
• UDI-Public: (01)08714729787365(17)20180228(10)18923606
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• 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): 12/06/2016

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: 02/28/2018
• Device Model Number: M00534270
• Device Catalogue Number: 3427
• Device Lot Number: 18923606
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/15/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/06/2016
• Initial Report FDA Received Date: 12/30/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1