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

Model Number	M00572240
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Approximated based on the date the manufacturer became aware of the event.Imdrf device code a15 captures the reportable investigation finding of stent partially deployed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2023, that an epic biliary endoscopic stent was to be implanted to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on an unknown date.During preparation, it was noted that the stent was partially deployed.Another epic biliary endoscopic stent was used to complete the procedure.No patient complications were 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: 16469222
• Report Number: 3005099803-2023-01104
• Device Sequence Number: 5133372
• Product Code: FGE
• UDI-Device Identifier: 08714729896869
• UDI-Public: 08714729896869
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/02/2023

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: 03/27/2024
• Device Model Number: M00572240
• Device Catalogue Number: 56705
• Device Lot Number: 0029119044
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/07/2023
• Initial Report FDA Received Date: 03/02/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/28/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown