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

Model Number	M00534330
Medical Device Problem Codes	Break (1069); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed; however, it was noticed that the introducer was released from the catheter.Subsequently, the introducer was retrieved.The stent was implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Imdrf device code a0401 captures the reportable event of catheter-guide break.
Additional Manufacturer Narrative
Block b5 has been updated with additional information received on september 19, 2024.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 biliary preloaded double bend stent was used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6), 2024.During the procedure, the stent was deployed; however, it was noticed that the introducer was released from the catheter.Subsequently, the introducer was retrieved.The stent was implanted, and the procedure was completed.There were no patient complications reported as a result of this event.Additional information received on september 19, 2024.The stent was implanted in the biliary.The broken introducer was retrieved with a snare and the procedure was completed with another advanix biliary preloaded stent.
Event or Problem Description
It was reported to boston scientific corporation that an advanix biliary preloaded double bend stent was used to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2024.During the procedure, the stent was deployed; however, it was noticed that the introducer was released from the catheter.Subsequently, the introducer was retrieved.The stent was implanted, and the procedure was completed.There were no patient complications reported as a result of this event.**additional information received on september 19, 2024** the stent was implanted in the biliary.The broken introducer was retrieved with a snare and the procedure was completed with another advanix biliary preloaded stent.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of catheter-guide break.Block h11: an advanix rx biliary preloaded double bend stent was received for analysis.Visual inspection found that the guide catheter was kinked and detached.Also, the push catheter was kinked.Destructive inspection was performed, and it was found that the device hypotube from the pull wire was detached from the guide catheter, and the pull wire was kinked.No other problems were noted with the device.Product analysis confirmed the reported event of catheter-guide break.It is most likely that the attempted deployment, the tortuosity of the patients anatomy, or the physician's technique caused the observed event of the catheter-guide kinked.Furthermore, by the time the stent was deployed, the push catheter was kinked along with the pull wire, which then resulted in the reported event of catheter-guide break which was either caused by the force that was pulled from the pull wire or by the pressure the kinked portion of the guide catheter added to the delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

• 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: 20204594
• Report Number: 3005099803-2024-04506
• Device Sequence Number: 6674654
• Product Code: FGE
• UDI-Device Identifier: 08714729787426
• UDI-Public: 08714729787426
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: K101314
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• 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,Followup
• Report Date (Section B): 11/06/2024

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: 04/02/2025
• Device Model Number: M00534330
• Device Catalogue Number: 3433
• Device Lot Number: 0033796777
• 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: 08/19/2024
• Supplement Date Received by Manufacturer: 09/19/2024; 10/14/2024
• Initial Report FDA Received Date: 09/12/2024
• Supplement Report FDA Received Date: 10/10/2024; 11/06/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/02/2024
• 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: Unknown