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

Model Number	M00572300
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/19/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block h6: imdrf device code a150207 captures the reportable event of delivery system difficult to remove.Imdrf device code a0501 captures the reportable event of inner sheath detached.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that epic biliary endoscopic stents were implanted in the left and right hepatic ducts to treat a malignant hilar stricture during a bilateral biliary stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, the stents were successfully implanted.However, during removal of the delivery system, the physician encountered difficulty removing the catheter.The inner sheath broke off while pulling out the delivery system.The detached inner sheath was removed from the patient using forceps and the procedure was completed.There were no reported patient complications as a result of this event.Note: a photo of the complaint device was provided by the complainant and showed a complete separation of the inner sheath.The distal section of the inner sheath was severely kinked at more than one location.

• 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: 16912561
• Report Number: 3005099803-2023-02530
• Device Sequence Number: 20438839
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 05/11/2023

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: 01/02/2025
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0030782420
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 05/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/03/2023
• 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