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

Model Number	M00534350
Medical Device Problem Codes	Obstruction of Flow (2423); Migration (4003)
Health Effect - Clinical Codes	Fatigue (1849); Cholangitis (4821)
Date of Event	06/16/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient's year of birth was 1968.
Event or Problem Description
This report is one of two complaints that pertain to the same event (mfr.Report #3005099803-2022-07113).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) 2021.Post procedure, the patient was admitted to the hospital for further workup.The patient was treated with zosyn for suspected cholangitis.The patient had a ct-scan in the emergency department, and it showed that the stent migrated from the right portal biliary duct into the common bile duct.On (b)(6) 2021, an ercp procedure was performed for stent removal.During the procedure, it was noted that two stents migrated and were obstructed.Both stents were successfully removed in this procedure.It was reported that two stents, one of the same model and other of a different model were successfully placed and have completed the procedure.On the following day, post procedure, the patient had experienced a slight increased abdominal pain.The increased fatigue was suspected to be secondary to the procedure versus acute pancreatitis.The condition of the patient was reported to have improved and was discharged.Discharge medication of oral levofloxacin and flagyl antibiotics were prescribed to the patient for a total of ten-day course.It was reported that there was no connection of the stent and the cholangitis, however, the patient improved after stent removal and antibiotics.On (b)(6) 2021, the stents that were placed on (b)(6) 2021 were removed.It was noticed that the stents had partially migrated.There were no new stents replaced after stent removal.

• Brand Name: ADVANIX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 15941014
• Report Number: 3005099803-2022-06992
• Device Sequence Number: 17743374
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter State: NH
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/07/2022

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: 09/22/2022
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0026061692
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/07/2022
• Initial Report FDA Received Date: 12/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male
• Patient Weight: 24 KG