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

Model Number	M00572340
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat a malignant stricture due to cancer during a biliary metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight but not tortuous and was dilated with hurricane dilatation balloon prior to stent placement.During the procedure, the physician deployed the epic biliary stent using the thumbwheel method; however, the stent was not deployed.During removal, the stent partially opened inside the scope, and it was partially released onto the delivery system when it was removed from the patient.The procedure was completed with a different device.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Imdrf device code a15 captures the reportable event of epic biliary endoscopic stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on march 14, 2023, that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat a malignant stricture due to cancer during a biliary metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight but not tortuous and was dilated with hurricane dilatation balloon prior to stent placement.During the procedure, the physician deployed the epic biliary stent using the thumbwheel method; however, the stent was not deployed.During removal, the stent partially opened inside the scope, and it was partially released onto the delivery system when it was removed from the patient.The procedure was completed with a different device.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of epic biliary endoscopic stent partially deployed.Block h10: the epic biliary endoscopic stent and delivery system were received for analysis.The stent was returned partially deployed on the delivery system.Visual and tactile inspection found kinks at more than one location; the stainless-steel shaft and rack were kinked at the same location, approximately 70 mm proximal of the pull grip; the rack was also found to have been separated; and the handle was found to have been separated into two sections.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported event as the stent was received partially deployed.The kink noted on the sheath, stainless-steel shaft, and rack most likely occurred due to an unintended interaction between the user and the device; however, it could not be identified if it happened during procedure or handling of the device post procedure.Additionally, it is not known as to why the customer separated the handle.Based on all available information, the investigation concluded that the reported event of stent partially deployed was probably due to anatomical factors encountered during procedure.It was reported that the patient anatomy was tight which most likely contributed to the resistance encountered when attempting to deploy the stent and resulted to partial stent deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.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 march 14, 2023, that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat a malignant stricture due to cancer during a biliary metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight but not tortuous and was dilated with hurricane dilatation balloon prior to stent placement.During the procedure, the physician deployed the epic biliary stent using the thumbwheel method; however, the stent was not deployed.During removal, the stent partially opened inside the scope, and it was partially released onto the delivery system when it was removed from the patient.The procedure was completed with a different device.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of epic biliary endoscopic stent partially deployed.Block h10: the epic biliary endoscopic stent and delivery system were received for analysis.The stent was returned partially deployed on the delivery system.Visual and tactile inspection found kinks at more than one location; the stainless-steel shaft and rack were kinked at the same location, approximately 70 mm proximal of the pull grip; the rack was also found to have been separated; and the handle was found to have been separated into two sections.No other issues were noted with the stent and delivery system.Product analysis confirmed the reported event of the stent being partially deployed.Most likely, anatomical and procedural factors encountered during the procedure limited the performance of the device and contributed to the reported event.Additionally, the patient's anatomy was tight, which most probably contributed to the resistance when attempting deployment of the stent, which resulted in the partial deployment of the stent that was noticed only when the device was removed from the patient.The damage on the sheath, stainless-steel shaft, and rack was most likely due to the handling of the device, and the separation on the handle could not be identified.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.

• 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: 16621320
• Report Number: 3005099803-2023-01612
• Device Sequence Number: 7305938
• 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): 06/13/2023

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: 04/06/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029189296
• 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: 03/14/2023
• Supplement Date Received by Manufacturer: 05/24/2023; 06/13/2023
• Initial Report FDA Received Date: 03/27/2023
• Supplement Report FDA Received Date: 06/09/2023; 06/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/07/2022
• 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: Unknown