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); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/19/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an advanix rx biliary preloaded double bend stent was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke off remaining in the prosthesis during the attempted release and it was subsequently removed using biopsy forceps.The procedure was completed with another advanix biliary preloaded stent.There were no patient complications reported as a result of this event.Note: 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 a0401captures the reportable event of guide catheter break.Block h11: the naviflex rx delivery system was returned for analysis.Visual inspection found that the pull wire, push catheter, and guide catheter were kinked.The push catheter suture hole was found torn.In addition, during the destructive test it was seen that the guide catheter was detached from the pull wire.The advanix stent was not returned.Product analysis confirmed the reported event of guide catheter break.The investigation concluded that the reported event and additional observed damages were most likely caused by the excessive force applied during the attempted stent deployment with the guide wire not fully retracted into the endoscope.Therefore, taking all available information into consideration, the overall root cause of the reported event is failure to follow instructions.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 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 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 rx biliary preloaded double bend stent was used in the biliary duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the guide catheter broke off remaining in the prosthesis during the attempted release and it was subsequently removed using biopsy forceps.The procedure was completed with another advanix biliary preloaded 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 cannot 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: 19742907
• Report Number: 3005099803-2024-03389
• Device Sequence Number: 7673988
• Product Code: FGE
• UDI-Device Identifier: 08714729787440
• UDI-Public: 08714729787440
• 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
• Report Date (Section B): 10/31/2024

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: 01/11/2026
• Device Model Number: M00534350
• Device Catalogue Number: 3435
• Device Lot Number: 0033197825
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2024
• Supplement Date Received by Manufacturer: 10/08/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 10/31/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2024
• 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 Age: 73 YR
• Patient Sex: Male