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

Model Number	M00572340
Medical Device Problem Codes	Use of Device Problem (1670); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2023
Type of Reportable Event	Malfunction
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 in the left and right hepatic ducts to treat a malignant hilar stricture during a hilar stricture metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the guidewire would not move forward and pass through the device delivery system.The epic biliary stent was removed, and the guidewire was loaded outside the patient, but it would still not move.The procedure was not completed because the same device was not available at the hospital.On (b)(6) 2023, the same procedure was performed on the patient.There were no reported patient complications as a result of this event.Note: it was reported that the guidewire used was a 0.25 guidewire.Per the dfu, the required guidewire to use is a 0.035 in (0.89 mm) stiff-bodied guidewire.The user did not use the required guidewire for the procedure.
Additional Manufacturer Narrative
The initial reporter address 1 is (b)(6).Impact code f05 captures the reportable event of delayed treatment/therapy.
Event or Problem Description
It was reported to boston scientific corporation on may 10, 2023, that an epic biliary endoscopic stent was to be implanted in the left and right hepatic ducts to treat a malignant hilar stricture during a hilar stricture metal stenting procedure performed on (b)(6) 2023.The patient's anatomy was tight and was dilated prior to stent placement.During the procedure, the guidewire would not move forward and pass through the device delivery system.The epic biliary stent was removed, and the guidewire was loaded outside the patient, but it would still not move.The procedure was not completed because the same device was not available at the hospital.On (b)(6) 2023, the same procedure was performed on the patient.There were no reported patient complications as a result of this event.Note: it was reported that the guidewire used was a 0.25 guidewire.Per the directions for use (dfu), the required guidewire to use is a 0.035 in (0.89 mm) stiff-bodied guidewire.The user did not use the required guidewire for the procedure.
Additional Manufacturer Narrative
Block e1: the initial reporter address 1: (b)(6).Block h6: impact code f05 captures the reportable event of delayed treatment/therapy.Imdrf device code a15 captures the reportable investigation result of stent partial deployment.The epic biliary endoscopic stent and delivery system were received for analysis.Visual inspection found the stent was partially deployed on the delivery system suggesting that the safety lock had been removed from the device.Visual and tactile examination found no damage to the delivery system.No other damages were noted on the delivery system.Product analysis did not confirm the reported event of the device being difficult to advance.The investigation concluded that this device was used in a manner inconsistent with the instructions for use(ifu)/product label.Partial stent deployment was evidence that the device safety lock had been removed prematurely.Additionally, a labeling review was performed, and from the information available, the guidewire used by the customer was size 0.25 inches which was not compatible with the device.Per the directions for use(dfu), the required guidewire to use is a 0.035 in (0.89 mm) stiff-bodied guidewire.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.

• 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: 17033107
• Report Number: 3005099803-2023-02870
• Device Sequence Number: 12489894
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/23/2023

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: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029961878
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/10/2023
• Supplement Date Received by Manufacturer: 08/03/2023
• Initial Report FDA Received Date: 05/31/2023
• Supplement Report FDA Received Date: 08/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/16/2022
• 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 Age: 50 YR
• Patient Sex: Male