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

Model Number	M00534700
Medical Device Problem Codes	Break (1069); Difficult or Delayed Positioning (1157)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded center bend stent was implanted in the ampulla of vater during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2023.The initial plan was to place two 10f x 9cm and one 10f x 7cm advanix stents into the common bile duct.During the procedure, after the first 10f x 9cm stent was successfully deployed, the second stent of the same size was deployed.However, the physician observed that the stent felt stiffer and encountered difficulty in deploying.Subsequently, the second stent was able to deploy; however, while checking the stent in full view after deployment, the physician noted a black tubing was still attached to the stent.Upon further investigation, it was determined that it was a portion of the delivery system that was detached.A forcep was then introduced and pulled the detached portion of the delivery system; however, it caused the stent to move slightly out of the ampulla.Despite having the 10f x 7cm stent being prepared for placement, the physician decided not to use the third stent due to the difficulty and movement of the second stent.The stents remained implanted and the procedure was completed.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Imdrf impact code f2301 captures the additional intervention to remove the detached portion of the delivery system using forceps.

• 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: 18278537
• Report Number: 3005099803-2023-06481
• Device Sequence Number: 6667336
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: 08714729787259
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/06/2023

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: 10/10/2025
• Device Model Number: M00534700
• Device Catalogue Number: 3470
• Device Lot Number: 0032617606
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/14/2023
• Initial Report FDA Received Date: 12/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown