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

Model Number	M00534700
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Retraction Problem (1536); 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	05/01/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was to be implanted in the duodenum for dilatation during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6)2024.During the procedure, the black guide catheter did not go into the sheath.The pull wire was pulled back but it was very stiff and got stuck.The device was removed, and it was noted that the black guide catheter was detached from the pull wire.Another advanix biliary stent was used to complete the procedure.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 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 guide catheter break.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Block h11: the advanix biliary stent-naviflex delivery system was received for analysis; the stent was still attached.Visual examination of the returned device found the pull wire was actuated and bent, the push catheter suture hole and the stent suture hole were torn.A guide wire was stuck within the advanix device.Functional inspection was performed, and it was observed that the pull wire cannot be retracted as it was stuck.During destructive test, it was observed that the guide catheter was detached from the pull wire's hypo tube.No other damages were noted to the stent and delivery system.Product analysis confirmed the reported events of guide catheter break, pull wire retraction problem, stent failure to deploy, and device use of device user error.A product labeling review identified that the device was used in a manner inconsistent with the ifu (instructions for use) / product label.The complainant reported that the guidewire was inside the patient during the attempted deployment as the 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 instruction for use (ifu); therefore, a review and analysis of all available information indicated that the most probable cause is failure to follow instructions.
Event or Problem Description
It was reported to boston scientific corporation that an advanix-naviflex rx biliary stent was to be implanted in the duodenum for dilatation during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on may 01, 2024.During the procedure, the black guide catheter did not go into the sheath.The pull wire was pulled back but it was very stiff and got stuck.The device was removed, and it was noted that the black guide catheter was detached from the pull wire.Another advanix biliary stent was used to complete the procedure.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 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: 19515157
• Report Number: 3005099803-2024-02734
• Device Sequence Number: 14329208
• Product Code: FGE
• UDI-Device Identifier: 08714729787259
• UDI-Public: 08714729787259
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 09/06/2024

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: 01/30/2026
• Device Model Number: M00534700
• Device Catalogue Number: 3470
• Device Lot Number: 0033329459
• 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: 05/21/2024
• Supplement Date Received by Manufacturer: 08/16/2024
• Initial Report FDA Received Date: 06/11/2024
• Supplement Report FDA Received Date: 09/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2024
• 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
• Patient Sex: Unknown