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

Model Number	M00534350
Medical Device Problem Codes	Obstruction of Flow (2423); Device Stenosis (4066)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/19/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure, performed on (b)(6) 2022.During the procedure, it was noted that the stent was occluded.A blood clot was noticed in the stent.There was no information on what stent completed the procedure.There were no patient complications reported as a result of this event.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient's year of birth was 1953.Block h6: medical device problem code a1409 captures the reportable event of stent obstruction within device.Block h11: additional information block a3; a4 and b5 has been updated based on additional information received october 27, 2022.This event was reported by other health care professional.The physician is: dr.(b)(6).
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent was used during a procedure, performed on (b)(6) 2022.During the procedure, it was noted that the stent was occluded.A blood clot was noticed in the stent.There was no information on what stent completed the procedure.There were no patient complications reported as a result of this event.Additional information received on october 27, 2022: during a stent removal and placement procedure, the stent was deployed in the common bile duct, however, it was noted that the stent was occluded, and blood clot was noticed.The stent was removed using a snare and the procedure was successfully completed with another advanix biliary stent.It was reported that when the previous stent was removed via snare, there was a moderate amount of bleeding and then the new stent was put in which is how the stent was filled with the blood.There was nothing mentioned in the note about any additional treatments or interventions for the bleeding that happened during the procedure.

• 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: 15664913
• Report Number: 3005099803-2022-06065
• Device Sequence Number: 12379762
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Study,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/22/2022

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: 03/21/2024
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0029085101
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/26/2022
• Supplement Date Received by Manufacturer: 10/27/2022
• Initial Report FDA Received Date: 10/25/2022
• Supplement Report FDA Received Date: 11/22/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 55 KG