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	05/22/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on may 23, 2023 that an epic biliary stent was used to treat a 6cm malignant stricture in the bile duct during a bilateral stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another epic biliary stent.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Initial reporter's phone number: (b)(6).Imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Block e1: initial reporter's phone number: (b)(6).Imdrf device code a15 captures the reportable event of stent partially deployed.An epic biliary delivery system was received for analysis; the deployed stent was not returned.Visual and tactile inspections found multiple kinks on the inner sheath.No other problems were noted to the delivery system.The observed event of inner sheath bent/kinked was most likely due to an interaction between the user and the device (unintended); however, at which stage of the procedure (during procedure/ handling post procedure) it occurred cannot be established.The reported event of stent partially deployed was not confirmed because the delivery system was received without the stent.Additional information was received confirming that the stent was deployed outside the patient prior to returning the device.It is most likely that the device may have encountered difficult patient anatomy such as extrinsic compression or severe angulation of the bile duct which causes difficulty in stent deployment and contributed to the reported event of stent partially deployed.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation on may 23, 2023 that an epic biliary stent was used to treat a 6cm malignant stricture in the bile duct during a bilateral stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, the stent was unable to deploy.The stent was partially deployed on the delivery system when it was removed from the patient.The procedure was completed with another epic biliary stent.There were no patient complications reported as a result of this event.

• 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: 17094123
• Report Number: 3005099803-2023-03097
• Device Sequence Number: 1907480
• 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): 09/11/2023

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: 09/21/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0030199041
• 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: 05/23/2023
• Supplement Date Received by Manufacturer: 08/21/2023
• Initial Report FDA Received Date: 06/08/2023
• Supplement Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2022
• 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
• Patient Race: Asian