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

Model Number	M00534360
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/25/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(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 stent was used during an endoscopic retrograde cholangiopancreatography procedure in the common bile duct, performed on (b)(6) 2018.According to the complainant, during the procedure, the stent could not be fully deployed.The physician noticed the guide catheter was still stuck inside the stent.When he tried to pull the pull wire harder, the guide catheter broke.The delivery system was completely pulled out from the patient and it was noticed under fluoroscopy that a part of the broken guide catheter remained stuck inside the stent.The piece of broken guide catheter was retrieved using a grasping forceps and the procedure was successfully 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 fine.

• 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: 7616147
• Report Number: 3005099803-2018-01948
• Device Sequence Number: 19221182
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/03/2019
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0020594609
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/25/2018
• Initial Report FDA Received Date: 06/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention