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

Model Number	M00533030
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/21/2017
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 visual evaluation of the returned device found that the stent was slightly bent in the middle and it presents scratches/damages in different locations.The proximal tip is torn.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, severe stricture due to patient anatomy.Continued effort to advance the device would cause damages to the stent.Most likely an additional device was used for retrieve the stent, this additional device could have contributed with the scratches/damages found on the device including the proximal tip torn.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A lot history search was performed and found one other complaint against lot number 19041763 for a similar issue from a different customer.
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 of a patient on (b)(6) 2017.According to the complainant, during the procedure, difficulty was experienced when they attempted to advance the advanix biliary stent into the patient's stricture site.The procedure was not completed due to this event.There were no patient complications reported, and 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: 6554899
• Report Number: 3005099803-2017-01353
• Device Sequence Number: 557822
• Product Code: FGE
• UDI-Device Identifier: 08714729786948
• UDI-Public: (01)08714729786948(17)20180331(10)19041763
• 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): 04/24/2017

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: 03/31/2018
• Device Model Number: M00533030
• Device Catalogue Number: 3303
• Device Lot Number: 19041763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/24/2017
• Initial Report FDA Received Date: 05/09/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1