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

Model Number	M00534320
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/14/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device was found that the suture hole is torn.The suture was broken and it was not returned with the device.The push catheter is kinked approximately at 12cm and 14cm from the distal end.The push catheter was cut to inspect the pull wire and it was observed that the pull wire was kinked.The guide catheter detached/broke from the delivery system.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 condition due to patient anatomy or customer use / manipulation / maneuvering can kink/bend the push catheter and pull wire, this condition can result in difficulty to deploy the stent.Continued attempts to deploy the stent and an excessive force applied to release it, can lead to tear the suture hole, break the suture and the guide catheter detachment from the delivery system.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 used for an an endoscopic retrograde cholangio-pancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2018.According to the complainant, during procedure when they attempted to deploy the stent it was unable to release from the pusher.The procedure was completed with another advanix¿ biliary stent.There were no patient complications reported as a result of this event, and the patient's condition at the conclusion of the procedure was reported to be "fine".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 - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7722344
• Report Number: 3005099803-2018-02293
• Device Sequence Number: 16326790
• Product Code: FGE
• UDI-Device Identifier: 08714729787419
• UDI-Public: 08714729787419
• Combination Product (Y/N): N
• Initial Reporter State: HI
• 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): 07/04/2018

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: 10/10/2019
• Device Model Number: M00534320
• Device Catalogue Number: 3432
• Device Lot Number: 21236219
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1