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

Model Number	M00572330
Medical Device Problem Codes	Entrapment of Device (1212); Problem with Sterilization (1596)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a180305 captures the reportable issue of device being stuck in scope, reprocessed, and used in another procedure.
Event or Problem Description
Note: this report pertains to one of two procedures involving one epic biliary stent.It was reported to boston scientific corporation on (b)(6) 2023 that an epic biliary stent was to be implanted in the common bile duct to treat a 6cm stricture during an endoscopic retrograde cholangiopancreatography (ercp) with 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, when the stent was being deployed, the radiopaque markers were unable to be seen on fluoroscopy.The stent was also not found deployed inside the patient's stomach and surrounding ducts.The device was removed and the procedure was completed with a wallflex biliary stent.On an unknown date, the same non-boston scientific scope was reprocessed and was used in a different procedure.During the procedure, a plastic stent was advanced through the scope but became stuck.When the scope was removed and checked, the epic biliary stent from the previous procedure was found deployed and was pulled out of the scope.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: 16487383
• Report Number: 3005099803-2023-01109
• Device Sequence Number: 6844264
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• 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: Other
• Type of Report: Initial
• Report Date (Section B): 03/06/2023

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: 08/15/2024
• Device Model Number: M00572330
• Device Catalogue Number: 7233
• Device Lot Number: 0029962062
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2023
• Initial Report FDA Received Date: 03/06/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female