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

Model Number	M00532210
Medical Device Problem Code	Kinked (1339)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).According to the complainant, the suspect device has been disposed and is not available for return.If any further relevant information is received, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix" biliary double pigtail stent was used in the bile duct during a bile duct stenting procedure performed on (b)(6) 2016.According to the complainant, during the procedure, it was observed that the pull wire was difficult to retract when pulled forcefully.Furthermore, it was noticed on the endoscope screen that the papilla side of the stent was wrinkled.The procedure was completed with this device.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.
Event or Problem Description
It was reported to boston scientific corporation that an advanix¿ biliary double pigtail stent was used in the bile duct during a bile duct stenting procedure performed on (b)(6) 2016.According to the complainant, during the procedure, it was observed that the pull wire was difficult to retract when pulled forcefully.Furthermore, it was noticed on the endoscope screen that the papilla side of the stent was wrinkled.The procedure was completed with this device.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 information received on 28nov2016: during the procedure, with ptgbd being implanted, a guide wire was inserted towards the papilla vater.The guide wire was being held by forceps within the intestinal tract.Then, stent release was attempted with rendezvous method and the event occurred.Resistance was met, and release was attempted forcefully.The stent was implanted, but it kinked/bent.They were unsure if it could provide drainage, so after implantation, they tried to remove the stent, but 'could not remove with resistance'.

• Brand Name: ADVANIX¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 6106964
• Report Number: 3005099803-2016-03482
• Device Sequence Number: 671855
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: (01)08714729786993(17)20180831(10)19611331
• Combination Product (Y/N): N
• PMA/510(K) Number: K101786
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2016
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/25/2016

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: Health Professional
• Device Expiration Date: 08/31/2018
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 19611331
• Was Device Available for Evaluation?: No
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 10/25/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/16/2016
• Supplement Report FDA Received Date: 12/19/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1