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

Model Number	M00534210
Medical Device Problem Code	Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/09/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report is one of three complaints that pertain to the same event (mfr report #3005099803-2022-06245, mfr report #3005099803-2022-06268.It was reported to boston scientific corporation that three advanix biliary stents were used during an endoscopic retrograde cholangiopancreatography procedure in the bile duct, performed on (b)(6) 2022.During the procedure, the physician had difficulty pushing the stents out of the endoscope.The patient had a bile duct anomaly and the physician did not have a good vision of the stent going into the bile duct.A blue area was visualized on the screen but the physician could not determine if the first stent was deployed.It appeared as though a part of the stent may have been blocking the lens view.The first stent was deployed prematurely and was then removed from the patient.There was difficulty in deploying the second stent as it appeared lost in the view but was then successfully deployed in the anatomy.The physician removed the endoscope and the third stent was successfully deployed.As a result, there was an approximately one and a half hour surgical delay and the intended procedure was not completed.The patient was scheduled to return another day to have the implanted stents removed by interventional radiology and new stents were successfully implanted.The customer reported it was unclear if there was an internal channel issue of the endoscope or if the distal cover contributed to any stent deployment issues.The distal cover and endoscope were inspected prior to the procedure and there were no issues identified.The distal cover was not inspected after the procedure for issues.No further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
(b)(4).

• 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: 15738159
• Report Number: 3005099803-2022-06270
• Device Sequence Number: 19562694
• Product Code: FGE
• UDI-Device Identifier: 08714729787303
• UDI-Public: 08714729787303
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 11/04/2022

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: 07/02/2023
• Device Model Number: M00534210
• Device Catalogue Number: 3421
• Device Lot Number: 0027600196
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/06/2022
• Initial Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/02/2021
• 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: Unknown