MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ADVANIX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00532220
Medical Device Problem Codes	Appropriate Device Problem Term/Code Not Available (3191); Migration (4003)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Ptient sex: 6 cases, including both males and females approximated based on the date the manufacturer became aware of the event.Implant date: between (b)(6).Explant date: between (b)(6).(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 medwatch will be filed.
Event or Problem Description
Boston scientific corporation received six complaints regarding six separate advanix biliary stent devices involved in separate procedures on different patients.It was reported to boston scientific corporation that six advanix biliary stents were used during endoscopic retrograde cholangiopancreatography (ercp) procedures performed in the common bile duct of six different patients.The six procedures were performed on between (b)(6).However, the exact implant dates were not reported.The six patients underwent planned stent removal procedures performed between (b)(6).The exact procedure dates were not reported.According to the complainant, during the planned stent removal procedures, the physician found that a double pigtail stent had migrated proximally in the duodenum for each case.The devices were removed and the procedures were cancelled/rescheduled.There were no patient complications reported as a result of this event.Each patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10791127
• Report Number: 3005099803-2020-05081
• Device Sequence Number: 13734780
• Product Code: FGE
• UDI-Device Identifier: 08714729787006
• UDI-Public: 08714729787006
• Combination Product (Y/N): N
• Initial Reporter Country: KU
• PMA/510(K) Number: K101786
• 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): 11/04/2020

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: 08/05/2021
• Device Model Number: M00532220
• Device Catalogue Number: 3222
• Device Lot Number: 0024220012
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/12/2020
• Initial Report FDA Received Date: 11/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1