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

Model Number	0025365406
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/17/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter state/province: (b)(6).(b)(4).The complainant indicated that the device was disposed 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
It was reported to boston scientific corporation that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct performed on (b)(6) 2020.According to the complainant, during the procedure, inside the patient, a problem occurred with the device.The procedure was cancelled due to this event.The exact nature of the device failure was not reported.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was noted 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: 10391262
• Report Number: 3005099803-2020-03234
• Device Sequence Number: 2801160
• Product Code: FGE
• UDI-Device Identifier: 08714729786986
• UDI-Public: 08714729786986
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 08/11/2020

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: 03/17/2022
• Device Model Number: 0025365406
• Device Catalogue Number: 3219
• Device Lot Number: 0025365406
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/17/2020
• Initial Report FDA Received Date: 08/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 62 YR
• Patient Weight: 70