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

Model Number	M00572290
Medical Device Problem Codes	Use of Device Problem (1670); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
Note: this report pertains to one of the four devices used on the same patient.Refer to manufacturer report # 3005099803-2023-03775, 3005099803-2023-03778, 3005099803-2023-03835, and 3005099803-2023-03836 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that four (4) epic biliary stents were to be implanted in the common bile duct at the hepatic bifurcation to treat a 2 cm malignant klatskin's tumor during an endoscopic retrograde cholangiopancreatography (ercp) with self-expandable metallic stent (sems) implantation procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, two epic biliary stents were attempted to be placed bilaterally at the same time.The first epic biliary stent (the subject of mfr.Report # 3005099803-2023-03775) was lodged in the working channel of the scope, the delivery system could not be advanced, and the stent was removed from the patient partially deployed on the delivery system.The second epic biliary stent (the subject of mfr.Report # 3005099803-2023-03778) was also difficult to advance through the scope, and the outersheath became buckled and kinked.During withdrawal, the second epic biliary stent became partially deployed on the delivery system.Another two epic biliary stents were opened and attempted to be placed bilaterally at the same time, and the same situation occurred.The third epic biliary stent (the subject of this report) was difficult to advance through the scope; the outer sheath was kinked, and the stent became partially deployed on the delivery system.The fourth epic biliary stent (the subject of mfr.Report # 3005099803-2023-03836) was also difficult to advance through the scope; the outer sheath was kinked, and the stent was partially deployed on the delivery system.A different device was used to complete the procedure.There were no reported patient complications as a result of this event.It was reported that the epic biliary devices were inserted in pairs during a bilateral stent placement procedure.Per the instructions for use (ifu), when treating multiple lesions, the most distal lesions should be stented first followed by the stenting of proximal lesions.Stenting in this order eliminates the need to cross and reduces the chance of dislodging stents that have already been placed.The user did not follow the steps of the ifu.

• 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: 17350073
• Report Number: 3005099803-2023-03835
• Device Sequence Number: 6079482
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/19/2023

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: 12/10/2023
• Device Model Number: M00572290
• Device Catalogue Number: 7229
• Device Lot Number: 0028532978
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/21/2023
• Initial Report FDA Received Date: 07/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/10/2021
• 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
• Patient Sex: Unknown