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

Model Number	M00534350
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Use of Device Problem (1670); Material Deformation (2976); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preload duodenal bend stent was used in the biliary tree to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when the stent was deployed, it was unable to be released from the catheter, but it was entirely deployed on the handle.Upon checking the endoscopic image, it was noted that the suture was wrapped around the flange of the stent.The physician tried to maneuver it away while the nurse pulled hard to deploy but the stent was still unable to be deployed.Subsequently, the physician pulled out the scope and the stent; however, it was noted that the guide catheter was broken into two pieces and was stuck in the scope.It was pulled out and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the delivery system 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 can not be fully deployed." the physician did not follow the steps cited in the ifu.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix rx biliary preloaded delivery system was received for analysis; the stent and the suture were not returned.Visual inspection found the guide catheter kinked and detached.Additionally, there was evidence that the pull wire was pulled.No other problems were noted with the delivery system.Product analysis confirmed the reported event of catheter-guide break; however, the reported events of stent failure to deploy and suture material twisted were not confirmed.A product labeling review identified that the device was not used in accordance with the instructions for use (ifu) / product label.The complainant reported that the guidewire was in the delivery system during the attempted deployment.However, the ifu states, "for preloaded system only: if the guidewire is not completely retracted into the endoscope, the stent can not be fully deployed." it is most likely that operational factors such as deployment technique of the stent and possible excess of force applied during pull wire retraction caused friction between the push catheter and the guide catheter which resulted in the reported event of catheter-guide break and the observed event of catheter-guide kinked.Also, the patient's tortuous anatomy was a possible contributing factor.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preload duodenal bend stent was used in the biliary tree to treat a biliary obstruction during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, when the stent was deployed, it was unable to be released from the catheter, but it was entirely deployed on the handle.Upon checking the endoscopic image, it was noted that the suture was wrapped around the flange of the stent.The physician tried to maneuver it away while the nurse pulled hard to deploy but the stent was still unable to be deployed.Subsequently, the physician pulled out the scope and the stent; however, it was noted that the guide catheter was broken into two pieces and was stuck in the scope.It was pulled out and the procedure was completed with another advanix biliary stent.There were no patient complications reported as a result of this event.Note: it was reported that the guidewire was in the delivery system 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 can not be fully deployed." the physician did not follow the steps cited in the ifu.

• 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: 19217940
• Report Number: 3005099803-2024-02006
• Device Sequence Number: 20568311
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/01/2024

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: 08/30/2025
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0032334625
• 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: 04/12/2024
• Supplement Date Received by Manufacturer: 06/05/2024
• Initial Report FDA Received Date: 04/30/2024
• Supplement Report FDA Received Date: 07/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/31/2023
• 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
• Patient Sex: Unknown