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

Model Number	M00572340
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Deformation (2976)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	05/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation on may 18, 2023 that an epic biliary endoscopic stent was to be implanted in the left hepatic duct to treat a 3cm malignant stenosis due to hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the catheter broke and the stent was unable to be deployed.The procedure was not completed.On (b)(6) 2023, an endoscopic ultrasound- hepaticogastrostomy was successfully performed.The patient experienced abnormal liver function tests and blood counts and was admitted to the hospital beyond standard of care.In the physician's assessment, the patient complications are related to the device or procedure.The patient's current condition was reported to be stable.A photo of the device provided by the complainant shows that the stent was fully covered by the outer sheath, the outer sheath was detached, and the inner sheath was kinked.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2401 captures the reportable event of abnormal liver function tests and blood counts.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of additional intervention performed to complete the procedure.
Additional Manufacturer Narrative
Block h6: imdrf patient code e2401 captures the reportable event of abnormal liver function tests and blood counts.Imdrf impact code f08 captures the reportable event of prolonged hospitalization.Imdrf impact code f23 captures the reportable event of additional intervention performed to complete the procedure.Block h10: an epic biliary endoscopic stent and delivery system were returned for analysis.Visual examination of the returned device found the stent fully covered by the outer sheath.The outer sheath was kinked at more than one location and was found detached approximately 790mm distal of the pull grip.The inner sheath was also kinked at more than one location and was detached approximately 930mm distal of the pull grip.The pull grip was fully retracted indicating that deployment of the stent had been attempted.No other problems were noted to the stent and delivery system.Taking all available information into consideration, the investigation concluded that the reported events and observed failures were likely due to factors encountered during the procedure.It was reported that the anatomy was tight/tortuous, and although the lesion was dilated prior to stent placement, it is possible that the dilation was not sufficient, which likely would have contributed to the resistance encountered when attempting deployment of the stent.The inner sheath and outer sheath kinking and outer sheath separation may have been due to excessive force being applied to the device when attempting to deploy the stent.The observed failure of inner sheath separation most likely occurred due to an unintended interaction between the user and the device.Therefore, a review and analysis of all the available information indicated that the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation on may 18, 2023 that an epic biliary endoscopic stent was to be implanted in the left hepatic duct to treat a 3cm malignant stenosis due to hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) bilateral stenting procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the catheter broke and the stent was unable to be deployed.The procedure was not completed.On (b)(6) 2023, an endoscopic ultrasound- hepaticogastrostomy was successfully performed.The patient experienced abnormal liver function tests and blood counts and was admitted to the hospital beyond standard of care.In the physician's assessment, the patient complications are related to the device or procedure.The patient's current condition was reported to be stable.A photo of the device provided by the complainant shows that the stent was fully covered by the outer sheath, the outer sheath was detached, and the inner sheath was kinked.

• 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: 17071308
• Report Number: 3005099803-2023-02984
• Device Sequence Number: 6129640
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/09/2023

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: 09/27/2024
• Device Model Number: M00572340
• Device Catalogue Number: 56705
• Device Lot Number: 0030236227
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/18/2023
• Supplement Date Received by Manufacturer: 09/20/2023
• Initial Report FDA Received Date: 06/06/2023
• Supplement Report FDA Received Date: 10/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/28/2022
• 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 Age: 74 YR
• Patient Sex: Male
• Patient Weight: 64 KG
• Patient Race: Asian