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

Model Number	M00572280
Medical Device Problem Codes	Use of Device Problem (1670); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-03778, for the associated device information.It was reported to boston scientific corporation on (b)(6) 2023, that 2 epic biliary stents were to be implanted in the common bile duct at the hepatic bifurcation to treat a malignant 2 cm klatskin's tumor during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During the procedure, the first epic biliary stent (the subject of this report) was stuck in the working channel of the scope and could not be advanced.The first stent was removed from the patient partially deployed on the delivery system.A second epic biliary stent (the subject of mfr.Report # 3005099803-2023-03778) was used, however, it was difficult to advance through the scope, and the deployment catheter became buckled and kinked.The second stent was removed from the patient partially deployed on the delivery system.The procedure was completed with a different stent.There were no reported patient complications as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Additional Manufacturer Narrative
Blocks b5 and h6 (device codes) have been updated with the additional information received on july 12, 2023.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.
Event or Problem Description
Note: this report pertains to one of the two devices used on the same patient.Refer to manufacturer report # 3005099803-2023-03778, for the associated device information.It was reported to boston scientific corporation on june 21, 2023, that 2 epic biliary stents were to be implanted in the common bile duct at the hepatic bifurcation to treat a malignant 2 cm klatskin's tumor during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tight and was not dilated prior to stent placement.During the procedure, the first epic biliary stent (the subject of this report) was stuck in the working channel of the scope and could not be advanced.The first stent was removed from the patient partially deployed on the delivery system.A second epic biliary stent (the subject of mfr.Report # 3005099803-2023-03778) was used, however, it was difficult to advance through the scope, and the deployment catheter became buckled and kinked.The second stent was removed from the patient partially deployed on the delivery system.The procedure was completed with a different stent.There were no reported patient complications as a result of this event.***additional information received on july12, 2023*** it was reported that four (4) epic biliary stents were attempted to be implanted bilaterally in pairs at the same time.The first epic biliary stent (the subject of this report) was not able to reach the lesion as it was difficult to advance through the scope.Additionally, the patient anatomy was tortuous.

• 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: 17304827
• Report Number: 3005099803-2023-03775
• Device Sequence Number: 6684499
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: 08714729896906
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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): 08/03/2023

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: 11/12/2023
• Device Model Number: M00572280
• Device Catalogue Number: 7228
• Device Lot Number: 0028378135
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 06/21/2023
• Supplement Date Received by Manufacturer: 07/12/2023
• Initial Report FDA Received Date: 07/12/2023
• Supplement Report FDA Received Date: 08/03/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/12/2021
• 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