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

Model Number	M00532960
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the stent is severely damaged, it is kinked in several locations and the proximal section is stretched and broken.Based on the product analysis, most likely some anatomical/procedural factors were encountered during the procedure which may have limited the overall performance of the device.A severe stricture due to patient anatomy or customer use/manipulation/maneuvering can lead to difficult to advance the device through the patient anatomy, continuous attempts to advance the device can cause damages to the stent.Likely an additional device was used for retrieve the stent, this additional device could have contributed with the damages found on the device including the proximal section stretched and broken.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.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 the common bile duct on (b)(6) 2017.According to the complainant, during the procedure, the stent was difficult to advance into 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 "fine".Investigation results revealed the stent was broken, therefore this event has been deemed an mdr reportable event.Please see block h10 for full investigation details.

• 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: 7266888
• Report Number: 3005099803-2018-00402
• Device Sequence Number: 1316724
• Product Code: FGE
• UDI-Device Identifier: 08714729786870
• UDI-Public: 08714729786870
• 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): 12/21/2017

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: 08/10/2019
• Device Model Number: M00532960
• Device Catalogue Number: 3296
• Device Lot Number: 0020991923
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/23/2018
• Initial Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1