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

Model Number	M00539290
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual examination of the returned device found that the proximal section of the guide catheter was broken but the broken section was not returned for analysis.The push catheter was also bent in several locations.The stent that was returned was loaded on the delivery system, it was held by the suture which indicates that the stent failed to deploy during procedure.Based on the product analysis.It most likely due to anatomical/procedural factors encountered during the procedure, performance was limited.A device under tortuous condition due to patient anatomy or customer use/manipulation/maneuvering can cause the device to bend/coil leading to kinks or bends in catheter.With the device bound by kinks/bends in catheter, the device would become difficult to retract the guide catheter and consequently the stent could be difficult to deploy.Continued effort to deploy the stent or excessive force retracting the guide catheter to release the stent likely caused breaking the guide catheter at proximal section which can result in failure to deploy the stent during the procedure.Therefore the most probable root cause is "operational context".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 a flexima biliary preloaded stent was used during an endoscopic retrograde cholangiopancreatography procedure performed in the common bile duct, performed on (b)(6) 2018.According to the complainant, during the procedure, the physician attempted to deploy the stent, however, the guide catheter could not be withdrawn.As a result, the stent could not be deployed.The case was successfully completed using another flexima stent of the same kind.There were no patient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 stable.Investigation results revealed the guide catheter was broken, therefore this event has been deemed an mdr reportable event.

• Brand Name: FLEXIMA¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7725961
• Report Number: 3005099803-2018-02310
• Device Sequence Number: 16369868
• Product Code: FGE
• UDI-Device Identifier: 08714729162605
• UDI-Public: 08714729162605
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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): 07/06/2018

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: 10/17/2020
• Device Model Number: M00539290
• Device Catalogue Number: 3929
• Device Lot Number: 21271029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/06/2018
• Initial Report FDA Received Date: 07/27/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1