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

Model Number	M00572340
Medical Device Problem Codes	Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/31/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on january 31, 2023, that an epic biliary endoscopic stent was to be implanted in the biliary tree to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedures performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedures, the epic biliary endoscopic stent did not deploy after clicking the thumb wheel multiple times and even using the manual pull grip method due to the constriction of the parallel blood vessel due to the first epic biliary endoscopic stent that was successfully deployed.The stent was removed from the patient, fully covered by the outer sheath, and the procedure was cancelled.Reportedly, no procedure was scheduled for another stent placement.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.A photo of the complaint device outside the patient was provided by the complainant and showed that the sheath was kinked.
Additional Manufacturer Narrative
Impact code f1001 is being used to capture the reportable event of cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation on january 31, 2023, that an epic biliary endoscopic stent was to be implanted in the biliary tree to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedures performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedures, the epic biliary endoscopic stent did not deploy after clicking the thumb wheel multiple times and even using the manual pull grip method due to the constriction of the parallel blood vessel due to the first epic biliary endoscopic stent that was successfully deployed.The stent was removed from the patient, fully covered by the outer sheath, and the procedure was cancelled.Reportedly, no procedure was scheduled for another stent placement.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo of the complaint device outside the patient was provided by the complainant and showed that the sheath was kinked.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled procedure.Block h10: the epic biliary stent was not returned; however, media analysis was performed based on the photo provided by the complainant.Per media analysis, the stent was fully constrained on the delivery system.The outer sheath where the stent was mounted was bent/kinked, and the outer sheath was detached at the handle (strain relief).No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of outer sheath kinked.Most likely anatomical and procedural factors encountered during the procedure, limited the performance of the device and contributed to stent deployment failure.It was reported that the patient anatomy was tortuous and was compressed by a parallel stented vessel.It is possible that when the delivery system was advanced and crossed the anatomy, the outer sheath got kinked and deployment would not be possible.Additionally, the amount of force applied in the attempt to deploy the stent could have caused the outer sheath to be detached/ separated from the handle.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.
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable event of cancelled procedure.Block h10: the epic biliary endoscopic stent and delivery system were received for analysis.The stent was returned fully mounted and in the correct location on the delivery system.Visual and tactile inspection identified multiple outer sheath kinks.The outer sheath was noted to be detached.Media analysis found that the outer sheath was kinked.No other issues were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent failure to deploy, the stent was unable to be deployed due to the outer sheath kinked and detached.The reported event of sheath kink was confirmed.Most likely, anatomical and procedural factors encountered during the procedure limited the performance of the device and contributed to stent deployment failure.It was reported that the patient's anatomy was tortuous and was compressed by a parallel stented vessel.It is possible that when the delivery system advanced and crossed the anatomy, the outer sheath got kinked, and deployment would not be possible.Additionally, the amount of force applied in the attempt to deploy the stent could have caused the outer sheath to be detached from the handle.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 january 31, 2023, that an epic biliary endoscopic stent was to be implanted in the biliary tree to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral stenting procedures performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedures, the epic biliary endoscopic stent did not deploy after clicking the thumb wheel multiple times and even using the manual pull grip method due to the constriction of the parallel blood vessel due to the first epic biliary endoscopic stent that was successfully deployed.The stent was removed from the patient, fully covered by the outer sheath, and the procedure was cancelled.Reportedly, no procedure was scheduled for another stent placement.There were no reported patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.Note: a photo of the complaint device outside the patient was provided by the complainant and showed that the sheath was kinked.

• 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: 16422651
• Report Number: 3005099803-2023-00868
• Device Sequence Number: 17478027
• 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,Followup
• Report Date (Section B): 06/02/2023

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: 08/16/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029966678
• 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: 01/31/2023
• Supplement Date Received by Manufacturer: 02/22/2023; 05/16/2023
• Initial Report FDA Received Date: 02/22/2023
• Supplement Report FDA Received Date: 03/17/2023; 06/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/17/2022
• 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 Age: 77 YR
• Patient Sex: Male