MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536470
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/12/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).(b)(6).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 an advanix pancreatic stent was used during a pancreatic stent placement performed on (b)(6) 2019.According to the complainant, during the procedure, when attempted to insert the stent, the tip of the stent got kinked, and since it might have a problem in drainage, the device was removed.The procedure was completed with advanix pancreatic stent.There were no patient complications reported as a result of this event.Attempts to ascertain the condition of the patient have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was used during a pancreatic stent placement performed on (b)(6) 2019.According to the complainant, during the procedure, when attempted to insert the stent, the tip of the stent got kinked, and since it might have a problem in drainage, the device was removed.The procedure was completed with advanix pancreatic stent.There were no patient complications reported as a result of this event.Attempts to ascertain the condition of the patient have been unsuccessful.Should additional relevant details become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
(b)(4).Block e1: (b)(6).Block h10: investigation results: a visual evaluation of the returned device found that the stent was kinked in several locations.The stent was inspected under magnification and it was observed marks over the stent surface indicating interaction with another device.Based on the product analysis, most likely some procedural/anatomical factors were 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 the stent, this condition can affect the overall performance of the device.Also interaction with additional devices/instruments can contribute with the encountered damaged.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 and no anomalies were found.

• Brand Name: ADVANIX PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8488811
• Report Number: 3005099803-2019-01648
• Device Sequence Number: 1871392
• Product Code: FGE
• UDI-Device Identifier: 08714729857419
• UDI-Public: 08714729857419
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K133700
• 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): 05/09/2019

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: 11/12/2019
• Device Model Number: M00536470
• Device Catalogue Number: 3647
• Device Lot Number: 0022125882
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 04/15/2019
• Initial Report FDA Received Date: 04/05/2019
• Supplement Report FDA Received Date: 05/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1