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

Model Number	M00539320
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A visual evaluation of the returned device found that the suture was broken and it was not returned with the device.The push catheter is bent in several locations.The distal section of the guide catheter is bent.The suture hole is torn.The proximal section of the stent is slightly bent.A functional analysis was performed and found that the guide catheter could be retracted and the stent was deployed, however, slight resistance was felt during the stent deployment.Based on the product analysis, 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 the catheters and the stent.With the device bound by bends in the catheters and the stent, the device would become difficult to retract the guide catheter and consequently the stent could not be deployed.Continued effort to deploy the stent likely caused tearing of the suture hole and suture breakage.Even though the stent was returned loaded on the delivery system, once the suture is broken, any backward movement could cause unintended deployment of stent.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 search of the complaint database confirmed that no similar complaints exist for the specified batch.
Event or Problem Description
It was reported to boston scientific corporation that a flexima¿ biliary stent was used in an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2016.According to the complainant, during the procedure, it was noticed that the stent was separated from the delivery system.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".This event has been deemed a reportable event based on the investigation results; stent kinked.

• 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: 6255788
• Report Number: 3005099803-2017-00050
• Device Sequence Number: 18854253
• Product Code: FGE
• UDI-Device Identifier: 08714729162636
• UDI-Public: (01)08714729162636(17)20180228(10)17731070
• 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): 12/22/2016

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: 02/28/2018
• Device Model Number: M00539320
• Device Catalogue Number: 3932
• Device Lot Number: 17731070
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/08/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2016
• Initial Report FDA Received Date: 01/17/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 44 YR
• Patient Weight: 54