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

Model Number	M00534360
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Use of Device Problem (1670); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device required to remove the broken guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be used for drainage in the hilar region of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent could not be deployed, and the guide catheter broke from the delivery system and detached with the stent inside the patient.The broken guide catheter and stent were removed using an additional device.The endoscope was then removed to retrieve the delivery system and stent trapped in the tip of the endoscope and the procedure was completed with another advanix biliary stent with naviflex rx delivery system.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be used for drainage in the hilar region of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.The patient's anatomy was tortuous.During the procedure, the stent could not be deployed, and the guide catheter broke from the delivery system and detached with the stent inside the patient.The broken guide catheter and stent were removed using an additional device.The endoscope was then removed to retrieve the delivery system and stent trapped in the tip of the endoscope and the procedure was completed with another advanix biliary stent with naviflex rx delivery system.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.Additional information received on march 6, 2024: it was reported that the delivery system was not trapped in the endoscope after the guide catheter broke and detached with the stent into the patient because the physician retired the device to introduce a biopsy forceps helping him to move the catheter from the common bile duct.
Additional Manufacturer Narrative
Blocks b5 and h6 have been updated with the additional information received on march 6, 2024.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device required to remove the broken guide catheter.
Additional Manufacturer Narrative
Blocks b5 and h6 have been updated with the additional information received on march 06, 2024.Block h6: imdrf device code a0401 captures the reportable event of a guide catheter break.Imdrf impact code f2301 captures the additional device required to remove the broken guide catheter.Block h10: the advanix biliary stent and naviflex rx delivery system were returned for analysis.Visual inspection found that the push catheter suture hole and the stent suture hole were torn.The guide catheter was found detached.No other damages were noted with the stent or the delivery system.Product analysis confirmed the reported event of guide catheter break, it was most likely caused by the force applied during the attempted stent deployment.However, the investigation also concluded that the observed damages could have happened because the instructions for use (ifu) were not followed or due to the complications that could have appeared during the procedure, making the guide catheter unable to handle the amount of pressure that was being used on it.A labeling review was performed, and from the information available, this device was used in a manner inconsistent with the instructions for use/product label.It was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." if the device was not deploying the stent due to the guide wire not being retracted, it is possible that the applied force when trying deployment made the stent suture hole and the push catheter suture hole got torn.Therefore, taking all available information into consideration, the overall root cause of the reported event is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary stent with naviflex rx delivery system was to be used for drainage in the hilar region of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2024.The patient's anatomy was tortuous.During the procedure, the stent could not be deployed, and the guide catheter broke from the delivery system and detached with the stent inside the patient.The broken guide catheter and stent were removed using an additional device.The endoscope was then removed to retrieve the delivery system and stent trapped in the tip of the endoscope and the procedure was completed with another advanix biliary stent with naviflex rx delivery system.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was inside the patient during the attempted deployment.However, the advanix biliary stent with naviflex rx delivery system instructions for use (ifu) states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent cannot be fully deployed." the physician did not follow the steps cited in the ifu.Additional information received on march 6, 2024 it was reported that the delivery system was not trapped in the endoscope after the guide catheter broke and detached with the stent into the patient because the physician retired the device to introduce a biopsy forceps helping him to move the catheter from the common bile duct.

• 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: 18839769
• Report Number: 3005099803-2024-00854
• Device Sequence Number: 12622218
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2024

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: 09/21/2025
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0032485801
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 02/08/2024
• Supplement Date Received by Manufacturer: 03/06/2024; 04/25/2024
• Initial Report FDA Received Date: 03/05/2024
• Supplement Report FDA Received Date: 03/28/2024; 05/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2023
• 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