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

Model Number	M00545560
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device was performed and found that the pull wire was kinked, the push catheter was kinked approximately at 2.5 cm from dital end, and the guide catheter was detached from the delivery system.Based on the product analysis, the issue occured during procedure.It is most likely that procedural or anatomical factors encountered during the procedure could have affected the device performance and its integrity.Patient anatomy and customer maneuvering during the use of the device can lead to kink/bend push catheter and pull wire.Once the push catheter is kinked at distal section, this condition can cause resistance at the moment to retract the pull wire/guide catheter, continued attempts to retract the pull wire/guide catheter or force applied retracting the pull wire in order to release the stent can result in guide catheter detachment due to friction between the components (push catheter/pull wire/guide catheter) at kinked area.Therefore, "adverse event related to procedure" is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used durin a stent placement procedure in the bile duct, performed on (b)(6) 2019.According to the complainant, during the procedure, the physician attempted to deploy the stent but the was difficult to advance.The procedure was successfully completed with another flexima rx biliary stent.This event has been deemed a reportable event based on the investigation results; guide catheter detached.There was no serious injury, nor were there any adverse patient effects reported as a result of this event.

• Brand Name: RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8759689
• Report Number: 3005099803-2019-03065
• Device Sequence Number: 19492379
• Product Code: FGE
• UDI-Device Identifier: 08714729337867
• UDI-Public: 08714729337867
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K965147
• 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): 07/03/2019

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: 01/27/2022
• Device Model Number: M00545560
• Device Catalogue Number: 4556
• Device Lot Number: 0023252974
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/16/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/11/2019
• Initial Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1