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

Model Number	M00572340
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an epic biliary stent was used in the biliary tree to treat a cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the first stent was successfully deployed; however, the epic biliary stent was unable to fully deploy even after all clicks on the thumbwheel were completed.The epic biliary stent was partially covered by the deployment suture on the delivery system when it was removed from the patient.The procedure was not completed as the deployed stent caused the parallel vessel to constrict and would not be possible to deploy another stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Imdrf device code a15 captures the reportable event of epic biliary stent partially deployed.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a15 captures the reportable event of epic biliary stent partially deployed.Block h10: an epic biliary delivery system was received for analysis; the stent was not returned.Visual and tactile inspections found multiple kinks on the inner sheath.No problems were noted on the handle; however, the safety clip was removed from the rack.No other problems were noted to the delivery system.Product analysis did not confirm the reported event of stent partially deployed as the stent was deployed from the delivery system and was not returned.It is most likely that the patient's tortuous anatomy contributed to the observed event of inner sheath kinked when the device was advanced to cross the target lesion which then resulted to the stent being unable to deploy.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an epic biliary stent was used in the biliary tree to treat a cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the first stent was successfully deployed; however, the epic biliary stent was unable to fully deploy even after all clicks on the thumbwheel were completed.The epic biliary stent was partially covered by the deployment suture on the delivery system when it was removed from the patient.The procedure was not completed as the deployed stent caused the parallel vessel to constrict and would not be possible to deploy another stent.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: EPIC 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; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 16452564
• Report Number: 3005099803-2023-00969
• Device Sequence Number: 5860423
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171809
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/01/2023

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: 08/15/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029961879
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/06/2023
• Supplement Date Received by Manufacturer: 05/16/2023
• Initial Report FDA Received Date: 02/28/2023
• Supplement Report FDA Received Date: 06/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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: Male