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

Model Number M00572330

Device Problems Premature Activation (1484); Poor Visibility (4072)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/13/2023

Event Type  malfunction  

Event Description

Note: this report pertains to one of two procedures involving one epic biliary stent.It was reported to boston scientific corporation on february 13, 2023 that an epic biliary stent was to be implanted in the common bile duct to treat a 6cm stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, when the stent was being deployed, the radiopaque markers were unable to be seen on fluoroscopy.The stent was also not found deployed inside the patient's stomach and surrounding ducts.The device was removed and the procedure was completed with a wallflex biliary stent.On an unknown date, the same non-boston scientific scope was reprocessed and was used in a different procedure.During the procedure, a plastic stent was advanced through the scope but became stuck.When the scope was removed and checked, the epic biliary stent from the previous procedure was found deployed and was pulled out of the scope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Imdrf device code a150103 captures the reportable event of stent premature deployment.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.An epic biliary endoscopic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the tip was detached and was not returned.The delivery system was separated in three sections.It was observed that the separation on the sheath was dissected using a sharp implement.The first dissection was located at the tip of the device, the second was located approximately 40mm proximal to the first and the third was located approximately 45mm proximal to the second.The inner sheath and the outer sheath was found severely kinked approximately 7mm distal to the pull grip.No other issues were noted to the stent and delivery system.It is most likely that the reported event of delivery system not visible under eus or fluoroscopy was due to the patient being overweight/clinically obese.The reported event of stent premature deployment was likely due to the stent being partially deployed when it was removed from the patient and was fully deployed due to the resistance within the scope.There is no evidence of stretching damage and it could be that the observed event of device separation occurred to the dissection with a sharp implement post removal of the device from the patient.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.

Event Description

Note: this report pertains to one of two procedures involving one epic biliary stent.It was reported to boston scientific corporation on february 13, 2023 that an epic biliary stent was to be implanted in the common bile duct to treat a 6cm stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, when the stent was being deployed, the radiopaque markers were unable to be seen on fluoroscopy.The stent was also not found deployed inside the patient's stomach and surrounding ducts.The device was removed and the procedure was completed with a wallflex biliary stent.On an unknown date, the same non-boston scientific scope was reprocessed and was used in a different procedure.During the procedure, a plastic stent was advanced through the scope but became stuck.When the scope was removed and checked, the epic biliary stent from the previous procedure was found deployed and was pulled out of the scope.There were no patient complications reported as a result of this event.

Event Description

Note: this report pertains to one of two procedures involving one epic biliary stent.It was reported to boston scientific corporation on (b)(6) 2023 that an epic biliary stent was to be implanted in the common bile duct to treat a 6cm stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement procedure.During the procedure, when the stent was being deployed, the radiopaque markers were unable to be seen on fluoroscopy.The stent was also not found deployed inside the patient's stomach and surrounding ducts.The device was removed and the procedure was completed with a wallflex biliary stent.On an unknown date, the same non-boston scientific scope was reprocessed and was used in a different procedure.During the procedure, a plastic stent was advanced through the scope but became stuck.When the scope was removed and checked, the epic biliary stent from the previous procedure was found deployed and was pulled out of the scope.There were no patient complications reported as a result of this event.

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.Block h10: an epic biliary endoscopic delivery system was received for analysis; the deployed stent was not returned.Visual examination of the returned device found the inner sheath of the delivery system was dissected into three sections using a sharp implement.The first dissection was located at the distal end of the delivery system and the distal tip was not returned.The second was located approximately 40mm proximal to the first, and the third was located approximately 45mm proximal to the second.The inner sheath and the outer sheath were also found severely kinked approximately 7mm distal to the pull grip.No other issues were noted to the delivery system.It is most likely that the reported event of delivery system not visible under eus or fluoroscopy was due to the patient being overweight/clinically obese.The reported event of stent premature deployment was likely due to the stent being partially deployed when it was removed from the patient and was fully deployed due to the resistance within the scope.There is no evidence of stretching damage and it could be that the observed event of device separation occurred to the dissection with a sharp implement post removal of the device from the patient.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.

• Brand Name: EPIC BILIARY
• Type of Device: 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: 16481988
• MDR Text Key: 310863455
• Report Number: 3005099803-2023-01101
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/16/2023

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
• Device Operator: Health Professional
• Device Model Number: M00572330
• Device Catalogue Number: 7233
• Device Lot Number: 0029962062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/13/2023
• Initial Date FDA Received: 03/03/2023
• Supplement Dates Manufacturer Received: 03/15/2023; 04/27/2023
• Supplement Dates FDA Received: 04/06/2023; 05/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/16/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Sex: Female