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

Model Number	M00572340
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/20/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Impact code f1001 is being used to capture the reportable issue of aborted/cancelled procedure.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023 that an epic biliary stent was used to treat a 5mm cholangiocarcinoma during a bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement procedure.During the procedure, the stent was unable to deploy even after complete rotation of the thumbwheel.The technician also tried the pull deployment method but the stent was still unable to deploy.The stent was fully covered by the outer sheath when it was removed from the patient.The procedure was not completed due to this event.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: 16708232
• Report Number: 3005099803-2023-01788
• Device Sequence Number: 17040305
• 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
• Report Date (Section B): 04/10/2023

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: 0030198159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/20/2023
• Initial Report FDA Received Date: 04/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: Female