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

Model Number M00534220

Device Problems Break (1069); Positioning Failure (1158); Retraction Problem (1536)

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

Event Date 02/10/2023

Event Type  Injury  

Event Description

It was reported to boston scientific that an advanix biliary stent was attempted to be placed in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2023.During stent placement in a very sick patient with a tight stricture, the stent would not release from the delivery system.Attempts were made to pull the stent and delivery system back through the scope, but the guide catheter and stent got stuck in the bile duct.The delivery system and half of the guide catheter were removed through the scope.The other half of the guide catheter and the stent were successfully removed from the bile duct using rat tooth forceps.The procedure to create flow in the duct was completed using a new advanix biliary stent.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code of a0401 captures the reportable event of guide catheter broken.Imdrf patient impact code f23 captures the reportable event of unexpected medical intervention.Imdrf patient impact code f2301 captures the reportable event of additional device required.

Manufacturer Narrative

Block h6: imdrf device code of a0401 captures the reportable event of guide catheter broken.Imdrf patient impact code f23 captures the reportable event of unexpected medical intervention.Imdrf patient impact code f2301 captures the reportable event of additional device required.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was detached from the delivery system.A microscope inspection was performed and found that the stent had scratch marks, the suture hole was slightly torn, and the guide catheter was slightly kinked.The reported event of guide catheter broken was confirmed.Taking all available information into consideration, it is possible that these failures may be related to manipulation of the device during the procedure and the reported tight anatomical structure could have been a contributing factor.Therefore, the most probable cause is adverse event related to procedure.

Event Description

It was reported to boston scientific that an advanix biliary stent was attempted to be placed in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6), 2023.During stent placement in a very sick patient with a tight stricture, the stent would not release from the delivery system.Attempts were made to pull the stent and delivery system back through the scope, but the guide catheter and stent got stuck in the bile duct.The delivery system and half of the guide catheter were removed through the scope.The other half of the guide catheter and the stent were successfully removed from the bile duct using rat tooth forceps.The procedure to create flow in the duct was completed using a new advanix biliary stent.There were no patient complications reported as a result of this event.

• 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: 16509277
• MDR Text Key: 310949456
• Report Number: 3005099803-2023-01027
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729787310
• UDI-Public: 08714729787310
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101314
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M00534220
• Device Catalogue Number: 3422
• Device Lot Number: 0030116158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/09/2022
• 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