MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION NAVIFLEX RX DELIVERY SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00533580
Medical Device Problem Codes	Break (1069); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix stent with naviflex rx delivery system was implanted to treat a hilar stricture of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the 10fr center bend advanix stent was placed into position.The assistant pulled back the blue handle to deploy the stent.However, when the handle was fully retracted, the black introducer broke away from the delivery system and remained inside the stent.The delivery system was removed, and a rat tooth device was used to extract the black introducer from within the stent.The procedure was successfully completed using the original device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdr impact code f2301 captures the used of rat tooth forceps to remove the broken guide catheter.
Event or Problem Description
It was reported to boston scientific corporation that an advanix with naviflex rx delivery system was implanted to treat a hilar stricture of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2024.During the procedure, the 10fr center bend advanix stent was placed into position.The assistant pulled back the blue handle to deploy the stent.However, when the handle was fully retracted, the black introducer broke away from the delivery system and remained inside the stent.The delivery system was removed, and a rat tooth device was used to extract the black introducer from within the stent.The procedure was successfully completed using the original device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter break.Imdr impact code f2301 captures the used of rat tooth forceps to remove the broken guide catheter.Block h11: an advanix- naviflex rx delivery system was returned for analysis; visual examination of the returned device found that the guide catheter was kinked, damaged, and detached from the delivery system and the pull wire was broken.No other problems were noted to the delivery system.Taking all available information into consideration, the investigation concluded that the reported event and observed problems were likely due to factors encountered during the procedure.Most likely procedural factors as lesion characteristics, handling of the device, the technique used by the physician (force applied), could have resulted in the damages and the detachments encountered in the device.Therefore, a review and analysis of the all the available information indicated that the most probable cause is adverse event related to procedure.

• Brand Name: NAVIFLEX RX DELIVERY SYSTEM
• 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: 20784403
• Report Number: 3005099803-2024-06026
• Device Sequence Number: 5052349
• Product Code: FGE
• UDI-Device Identifier: 08714729787105
• UDI-Public: 08714729787105
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 02/06/2025

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: 07/25/2026
• Device Model Number: M00533580
• Device Catalogue Number: M00533580
• Device Lot Number: 0034510815
• 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: 10/30/2024
• Supplement Date Received by Manufacturer: 01/17/2025
• Initial Report FDA Received Date: 11/26/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/25/2024
• 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 Sex: Prefer Not To Disclose