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

Model Number	M00534350
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Perforation (2001)
Date of Event	05/04/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.(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 a previously implanted advanix biliary stent was removed from a patient during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the bile duct performed on (b)(6) 2020.The exact implant date was not reported.According to the complainant, during the patient regular checkup, it was noticed that the stent had migrated distally and perforated the duodenal wall of the patient.The perforation was confirmed through endoscopy.The physician was able to remove the stent from the patient using graspers.No new stent was reported to replace the migrated stent.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be fully recovered.

• 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: 11127473
• Report Number: 3005099803-2020-06531
• Device Sequence Number: 4422169
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/06/2021

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 Model Number: M00534350
• Device Catalogue Number: 3435
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/10/2020
• Initial Report FDA Received Date: 01/06/2021
• 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