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

Model Number	M00545670
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/26/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Although the suspect device has been received, the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used in a tube stent placement performed in bile duct on (b)(6) 2018.According to the complainant, during the procedure, when they deploy the stent, the guide catheter detach from the delivery system and remained within the stent inside the patient.The stent and the detached guide catheter were retrieved using forceps.Attempts to gain additional information have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A visual evaluation of the returned device found that the push and guide catheter were kinked in several locations.It was also found that the guide catheter was broken at distal section.Based on product analysis, the failures found (push catheter/guide catheter kinked and guide catheter broken) are issues that could have been generated by excessive manipulation of the device by the user and/or excess of force applied to the product.A customer use/manipulation/maneuvering 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 to retract the guide catheter; excessive force used can cause the guide catheter damaged which is consistent with the analysis of the returned product performed.The guide catheter was found kinked and 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.
Event or Problem Description
It was reported to boston scientific corporation that a flexima rx biliary stent was used in a tube stent placement performed in bile duct on (b)(6) 2018.According to the complainant, during the procedure, when they deploy the stent, the guide catheter detach from the delivery system and remained within the stent inside the patient.The stent and the detached guide catheter were retrieved using forceps.Attempts to gain additional information have been unsuccessful to date.Should additional relevant details become available, a supplemental report will be submitted.

• 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: 7801267
• Report Number: 3005099803-2018-60075
• Device Sequence Number: 19317663
• Product Code: FGE
• UDI-Device Identifier: 08714729301844
• UDI-Public: 08714729301844
• 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,Followup
• Report Date (Section B): 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 04/03/2021
• Device Model Number: M00545670
• Device Catalogue Number: 49835
• Device Lot Number: 0021945451
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/18/2018
• Initial Date Received by Manufacturer: 07/27/2018
• Supplement Date Received by Manufacturer: 09/03/2018
• Initial Report FDA Received Date: 08/21/2018
• Supplement Report FDA Received Date: 09/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention