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

Model Number	M00534220
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/27/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary stent was implanted in a patient during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct, performed on (b)(6) 2018.According to the complainant, during a ptc (percutaneous transhepatic cholangiography) rendevous case where the guidewire was placed by interventional radiology, the advanaix stent was placed using the guidewire.When the physician was going to deploy the stent, he requested the guidewire be cut by the biopsy channel of the duodenocope.The physician requested the guidewire to be cut to prevent contamination, as the physician was expecting this portion of the guidewire to be pulled back through the patient's liver.The cut portion of the guidewire was attempted to be removed from the patient via the ptc site but became stuck when removing from the patient.The physician asked for the stent to be deployed with the guidewire still in place.After deployment, the guidewire was still unable to be removed from the patient via the ptc site, so the physician removed the delivery catheter and guidewire through the ercp scope.All devices were removed from the patient.After stent deployment it was noted that the distal flange was detached, it was found inside the ercp scope.Apparently the cut edge of the guidewire caught either the suture or flange of the stent.The stent reportedly migrated proximal into the common bile duct and the procedure was completed with this device.The stent is still implanted in the patient.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¿ BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - SPENCER; 780 brookside drive; spencer IN 47460
• MDR Report Key: 7549748
• Report Number: 3005099803-2018-01634
• Device Sequence Number: 16568477
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/04/2018

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: 09/06/2019
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 21097791
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 85 YR