MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00534320
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/16/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the push catheter and the guide catheter were found to be kinked in several locations, also, the guide catheter was found broken at its distal section.A functional analysis could not be performed due to the findings/damages encountered during the evaluation of the returned product are indicating that likely there were issues during the stent deployment.Based on the product analysis, it is possible that the way in which the device was handled and manipulated may have contributed to the failure encountered that can cause the device to bend/coil leading to kinks and bends in catheters.With the catheters bound by kinks and bends, the device would become difficult retract the guide catheter; excessive force used can also cause the guide catheter got damaged which is consistent with the analysis of the returned product performed since the guide catheter was found to be broken which at the same time can cause difficulties during deployment of the stent in a clinical setting.Therefore, 'cause traced to component failure' 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 used an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in the common bile duct on (b)(6) 2018.According to the complainant, during the procedure, the stent was failed to deploy.The procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; guide catheter broke.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8009566
• Report Number: 3005099803-2018-61060
• Device Sequence Number: 1394699
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 10/26/2018

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: 07/07/2020
• Device Model Number: M00534320
• Device Catalogue Number: 49844
• Device Lot Number: 0022345797
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2018
• Initial Report FDA Received Date: 10/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1