MAUDE Adverse Event Report: BOSTON SCIENTIFIC - SPENCER ADVANIX¿ PANCREATIC STENT; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00536560
Medical Device Problem Code	Kinked (1339)
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
Exact patient age unknown, but reported to be over 18 years of age.Device code relates to problem code for the reported event of "stent kinked".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 to be used for pancreatic duct stent placement procedure performed in the pancreatic duct on (b)(6) 2018.According to the complainant, during preparation, when flushing was performed by saline, the physician found a small bend in the flap part.The procedure was complete with another advanix¿ pancreatic stent.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 "good".
Additional Manufacturer Narrative
A visual evaluation was performed and no visual defects were noted.The returned product looks under good conditions without evidence of damages or anomalies.The flaps of the returned unit were specifically inspected and there were no kinks, bents and/or deformities found on any section.Therefore, "not confirmed - returned" is selected as the most probable root cause for the complaint.The device history record review was performed and no deviation was found.
Event or Problem Description
It was reported to boston scientific corporation that an advanix pancreatic stent was to be used for pancreatic duct stent placement procedure performed in the pancreatic duct on (b)(6) 2018.According to the complainant, during preparation, when flushing was performed by saline, the physician found a small bend in the flap part.The procedure was complete with another advanix pancreatic stent.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 "good".

• Brand Name: ADVANIX¿ PANCREATIC STENT
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7656940
• Report Number: 3005099803-2018-02039
• Device Sequence Number: 16410197
• Product Code: FGE
• UDI-Device Identifier: 08714729857501
• UDI-Public: 08714729857501
• Combination Product (Y/N): N
• 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): 06/06/2018

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: 10/02/2019
• Device Model Number: M00536560
• Device Catalogue Number: 3656
• Device Lot Number: 21951381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Initial Date Received by Manufacturer: 06/06/2018
• Supplement Date Received by Manufacturer: 07/04/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1