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

Model Number	M00572260
Medical Device Problem Codes	Device Contamination with Chemical or Other Material (2944); Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/16/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150101 captures the reportable event of stent failure to expand.Imdrf device code a180104 captures the reportable event of foreign material present in device.
Event or Problem Description
Note: this report pertains to one of three devices used during the same procedure.Refer to manufacturer report # 3005099803-2023-06025 and 3005099803-2023-06027 for the associated device information.During the procedure, an epic biliary stent was deployed; however, a "white band or material" was noted on the distal end of the stent causing the stent being unable to expand despite multiple attempts.A cannula and hurricane balloon were used to facilitate the expansion of the stent; however, the hurricane balloon was unable to advance.Eventually, the stent was able to expand and another epic biliary stent was deployed; however, the same issue occurred, thus, the stent was then removed with forceps.Subsequently, another epic biliary stent was deployed but the same issue was noted but was eventually able to expand after a hurricane balloon was used to break the "white band or material".Consequently, these problems prolonged the procedure to 45 minutes.The two epic biliary stents remained implanted and the procedure was completed.There were no patient complications reported as a result of these events.

• 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: 18095198
• Report Number: 3005099803-2023-06026
• Device Sequence Number: 15134923
• Product Code: FGE
• UDI-Device Identifier: 08714729896883
• UDI-Public: 08714729896883
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/14/2024
• Device Model Number: M00572260
• Device Catalogue Number: 7226
• Device Lot Number: 0030539137
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/16/2023
• Initial Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown