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

Model Number	M00572310
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation on november 8, 2022, that an epic biliary endoscopic stent was to be implanted to treat a 6cm stenosis in the distal bile duct due to pancreatic cancer during an endoscopic biliary stent placement procedure performed on (b)(6) 2022.The patient's anatomy was not dilated prior to stent placement.During the procedure, the epic biliary stent did not deploy despite the physician pulling the outer sheath back and forth.The physician then decided to remove the device; however, during removal, the delivery system became stuck in an upright position at the tip of the scope, and the epic biliary stent deployed prematurely inside the scope.The epic biliary stent was removed together with the scope, and the proximal end of the stent was noted to be kinked.A plastic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
(b)(4).

• 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: 15885202
• Report Number: 3005099803-2022-07040
• Device Sequence Number: 5123187
• Product Code: FGE
• UDI-Device Identifier: 08714729896937
• UDI-Public: 08714729896937
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 11/30/2022

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: 02/21/2024
• Device Model Number: M00572310
• Device Catalogue Number: 7213
• Device Lot Number: 0028906891
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 11/30/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2022
• 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