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

Model Number	M00536520
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/02/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was under the age of 18.A visual evaluation of the returned device found that the stent was kinked in several locations.Based on product analysis, the issue was noted during procedure and inside the patient, which indicates that the product was used within the surgical intervention; probably procedural or anatomical factors of the procedure affected the device performance and its integrity.It is most likely that during its manipulation the device could have been damaged, since the failure found (stent kinked) is a known issue that could have been generated by excessive manipulation of the device by the user, excess of force applied to the product and/or the interaction with other devices; under this condition (stent kinked) the product performance will be directly affected; the stent cannot be properly placed/deployed into the patient and resistance or difficulties during procedure can appear.Therefore, ¿operational context¿ is selected as the most probable root cause for the complaint.A review of the device history record (dhr) was performed and no deviation was found.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 duct stent placement procedure in the pancreatic duct, performed on (b)(6) 2018.According to the complainant, during the procedure, when the stent was positioned in the main pancreatic duct for deployment, the physician attempted to pull the pull wire but severe resistance was encountered and the stent failed to deploy.The procedure was completed using a different device.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation results; stent kinked.Please see results of manufacturer's final investigation.

• 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: 7632434
• Report Number: 3005099803-2018-01924
• Device Sequence Number: 13900250
• Product Code: FGE
• UDI-Device Identifier: 08714729857464
• UDI-Public: 08714729857464
• 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
• Report Date (Section B): 05/28/2018

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: 04/24/2019
• Device Model Number: M00536520
• Device Catalogue Number: 3652
• Device Lot Number: 21303831
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/08/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/28/2018
• Initial Report FDA Received Date: 06/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1