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

Model Number	M00534340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/17/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Medical device code a0401 captures the reportable event of guide catheter broken.
Event or Problem Description
It was reported to boston scientific corporation that a advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2023.During the procedure, it was found that the guide catheter became broken when the stent inserted into the delivery system, the procedure was successfully completed with different brand of device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable event of guide catheter broken.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2301 captures the reportable event of additional device required.Block h10: the returned advanix biliary stent was analyzed, and a visual evaluation noted that the guide catheter was kinked and detached from the pull wire.Also, the suture was detached from the push catheter and the pull wire was fully retracted from the stent, with the pull wire cap detached.Evidence of deployment attempt was made.No other problems with the device were noted.The reported event of guide catheter break and failure to deploy the stent was confirmed.Taking all available information into consideration, it is possible that these device problems could have been caused by anatomical factors or the technique used during the procedure.Most likely, excess of force was applied in order to release the stent causing the kinks on the pull wire and the cap detachment.Therefore, the most probable cause is adverse event related to the procedure.
Event or Problem Description
It was reported to boston scientific corporation that a advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) procedure in the common bile duct performed on (b)(6) 2023.During the procedure, it was found that the guide catheter became broken when the stent was inserted into the delivery system, the procedure was successfully completed with different brand of device.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Additional information received on february 9,2023, clarifying that the broken guide catheter was removed from the patient using a snare.

• 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: 16311582
• Report Number: 3005099803-2023-00527
• Device Sequence Number: 7049253
• Product Code: FGE
• UDI-Device Identifier: 08714729787433
• UDI-Public: 08714729787433
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/07/2023

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: 03/31/2023
• Device Model Number: M00534340
• Device Catalogue Number: 3434
• Device Lot Number: 0027065122
• 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: 01/17/2023
• Supplement Date Received by Manufacturer: 02/09/2023
• Initial Report FDA Received Date: 02/07/2023
• Supplement Report FDA Received Date: 03/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/31/2021
• 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