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

Model Number M00534360

Device Problems Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Use of Device Problem (1670)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/07/2024

Event Type  Injury  

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 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 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.

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.

• Brand Name: ADVANIX BILIARY
• Type of Device: 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
• MDR Text Key: 336924675
• Report Number: 3005099803-2024-00854
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787457
• UDI-Public: 08714729787457
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534360
• Device Catalogue Number: 3436
• Device Lot Number: 0032485801
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/22/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention