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

Model Number	M00534200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/01/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device is not available for return; 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 biliary stent was successfully implanted during an endoscopic retrograde cholangiopancreatography (ercp) procedure.Post procedure, it was reported that the patient had acquired infection.A stent removal procedure was performed.The event date was not reported.It was noted that the physician found a white secretions coming out from the duct.The advanix biliary stent was removed from the patient and successfully completed the procedure.Medication for infection were prescribed to the patent.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 "fully recovered".The device has not been returned for analysis.

• 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: 12125844
• Report Number: 3005099803-2021-03168
• Device Sequence Number: 4341891
• Product Code: FGE
• UDI-Device Identifier: 08714729787297
• UDI-Public: 08714729787297
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 07/06/2021

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/01/2021
• Device Model Number: M00534200
• Device Catalogue Number: 3420
• Device Lot Number: 0024531557
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/08/2021
• Initial Report FDA Received Date: 07/06/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention