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

Model Number	M00536630
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/06/2016
Type of Reportable Event	Malfunction
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 an advanix¿ pancreatic stent was used during a pancreatic ductal stent placement procedure performed in the pancreatic duct on (b)(6) 2016.According to the complainant, during insertion, resistance was felt and the advanix¿ pancreatic stent did not come out from the forceps channel of the endoscope.The endoscope was removed from the patient.When attempting to remove the stent from the scope, the physician reported that there was a ¿white object¿ attached to the flap of the stent.The physician assessed that this may have been the cause of the resistance met during insertion.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event 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 a foreign material was received with the stent.Additionally, the stent had residues indicating handling/manipulation, it also presented damages throughout.According to the complaint information the issue occurred during procedure, while the device was being introduced.Manipulation/handling of the device during procedure can lead to damages (scratches) to the stent, most likely the scratches found on the stent were caused due to procedural or anatomical factors encountered during procedure.Therefore, ¿operational context¿ is selected as the primary root cause for damages found on the stent.Regarding the foreign material received, at this moment it is unknown whether it is tissue, calcification, whether the particle was inside the scope before procedure.Since this information could not be verified, the most probable root cause for the complaint event is undeterminable since review and analysis of all available information fails to indicate a root cause or probable root cause.Therefore, ¿undeterminable¿ is selected as the secondary root cause for the foreign matter returned with the stent.A review of the device history record (dhr) confirms that the accepted device met all manufacturing specifications.A search of the complaint database revealed that no similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ pancreatic stent was used during a pancreatic ductal stent placement procedure performed in the pancreatic duct on (b)(6) 2016.According to the complainant, during insertion, resistance was felt and the advanix¿ pancreatic stent did not come out from the forceps channel of the endoscope.The endoscope was removed from the patient.When attempting to remove the stent from the scope, the physician reported that there was a ¿white object¿ attached to the flap of the stent.The physician assessed that this may have been the cause of the resistance met during insertion.The procedure was completed with a different device.There were no patient complications reported as a result of this event.Attempts to obtain additional information regarding the circumstances surrounding this event have been unsuccessful to date.Should additional relevant details become available; a supplemental report will be submitted.

• 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: 6217938
• Report Number: 3005099803-2016-04078
• Device Sequence Number: 19028750
• Product Code: FGE
• UDI-Device Identifier: 08714729857570
• UDI-Public: (01)08714729857570(17)20170531(10)18696029
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2016

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: Physician
• Device Expiration Date: 05/31/2017
• Device Model Number: M00536630
• Device Catalogue Number: 3663
• Device Lot Number: 18696029
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 12/07/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 01/03/2017
• Supplement Report FDA Received Date: 02/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1