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

Model Number	M00572340
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat an 8cm malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the epic biliary stent could not be deployed more than 10% of its length.The thumbwheel and the pull grip were both utilized to deploy the epic biliary stent but was unsuccessful.The epic biliary stent was removed from the patient partially deployed on the delivery system and a different device was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of a partially deployed epic biliary endoscopic stent.Block h10: an epic biliary endoscopic stent and delivery system were received for analysis.The stent was returned partially deployed.Visual examination of the returned device found multiple kinks along the sheath.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The kinks observed on the outer sheath could have occurred due to resistance met while advancing the delivery system along the guidewire through the stricture.Based on the available information, the investigation concluded that the reported event was most likely due to anatomical factor, such as tortuous anatomy.This could have contributed to multiple kinks found on the delivery system and would result to stent partial deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to patient condition.A product labeling review identified that the device was used per the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation on august 17, 2022, that an epic biliary endoscopic stent was to be implanted in the common bile duct to treat an 8cm malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with self-expanding metal stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the epic biliary stent could not be deployed more than 10% of its length.The thumbwheel and the pull grip were both utilized to deploy the epic biliary stent but was unsuccessful.The epic biliary stent was removed from the patient partially deployed on the delivery system and a different device was implanted to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.

• 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: 15381561
• Report Number: 3005099803-2022-05084
• Device Sequence Number: 5809680
• 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): 11/08/2022

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: 01/31/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0028775885
• 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: 08/17/2022
• Supplement Date Received by Manufacturer: 10/19/2022
• Initial Report FDA Received Date: 09/08/2022
• Supplement Report FDA Received Date: 11/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/31/2022
• 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 Sex: Unknown