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

Model Number	M00572340
Medical Device Problem Codes	Break (1069); Use of Device Problem (1670); Failure to Advance (2524); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.(b)(4).The epic biliary endoscopic stent and delivery system were received for analysis.Visual examination of the returned device found multiple kinks along the sheath and the tip was missing.The epic biliary stent was still inside the outer sheath and the safety lock was missing.The handle was disassembled to check the proximal end separation and the inner liner appeared to be separated 255 cm from the flushing port.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of kink and separation; the outer sheath was kinked, and the inner liner was detached.A product labeling review was performed and, from the information available, this device was used in a manner inconsistent with the dfu (directions for use) / product label.The complainant reported that the device was implanted to treat a benign stricture.The dfu states, "the epic biliary endoscopic stent system is indicated for palliation of malignant neoplasms in the biliary tree.Contraindications for the use of the epic biliary endoscopic stent system include placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown." this suggests that the damages were likely caused because of the contraindicated use.Therefore, a review and analysis of all available information indicated the most probable cause is cause traced to intentional off-label, unapproved, or contraindicated use.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the bile duct to treat a 6cm benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, while advancing the epic biliary delivery system through the stricture, the outer sheath kinked and broke.Consequently, the epic biliary delivery system was unable to advance to the target anatomy.The epic biliary endoscopic stent was removed from the patient fully covered by the outer sheath and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.It was reported that the epic biliary endoscopic stent was to be implanted to treat a benign stricture.However, per epic biliary endoscopic stent system directions for use (dfu), the device is indicated for palliation of malignant neoplasms in the biliary tree.The epic biliary stent is contraindicated for placement in biliary strictures caused by benign tumors.Note: this complaint has been deemed an mdr reportable event based on the product investigation which revealed the inner sheath was detached/ separated.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the bile duct to treat a 6cm benign stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, while advancing the epic biliary delivery system through the stricture, the outer sheath kinked and broke.Consequently, the epic biliary delivery system was unable to advance to the target anatomy.The epic biliary endoscopic stent was removed from the patient fully covered by the outer sheath and the procedure was completed with a different device.There were no patient complications reported as a result of this event.The patient condition following the procedure was reported to be stable.It was reported that the epic biliary endoscopic stent was to be implanted to treat a benign stricture.However, per epic biliary endoscopic stent system directions for use (dfu), the device is indicated for palliation of malignant neoplasms in the biliary tree.The epic biliary stent is contraindicated for placement in biliary strictures caused by benign tumors.Note: this complaint has been deemed an mdr reportable event based on the product investigation which revealed the inner sheath was detached/ separated.Please see block h10 for full investigation detail.***additional information received on october 12, 2022*** it was reported the 2 epic stents were used in the same case for bilateral stenting.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on (b)(6)2022.Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code (b)(6)captures the reportable investigation result of inner sheath detached.Block h10: the epic biliary endoscopic stent and delivery system were received for analysis.Visual examination of the returned device found multiple kinks along the sheath and the tip was missing.The epic biliary stent was still inside the outer sheath and the safety lock was missing.The handle was disassembled to check the proximal end separation and the inner liner appeared to be separated 255 cm from the flushing port.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of kink and separation; the outer sheath was kinked, and the inner liner was detached.A product labeling review was performed and, from the information available, this device was used in a manner inconsistent with the dfu (directions for use) / product label.The complainant reported that the device was implanted to treat a benign stricture.The dfu states, "the epic biliary endoscopic stent system is indicated for palliation of malignant neoplasms in the biliary tree.Contraindications for the use of the epic biliary endoscopic stent system include placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown." this suggests that the damages were likely caused because of the contraindicated use.Therefore, a review and analysis of all available information indicated the most probable cause is cause traced to intentional off-label, unapproved, or contraindicated use.

• 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: 15586848
• Report Number: 3005099803-2022-05916
• Device Sequence Number: 16825383
• 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): 11/01/2022

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: 11/12/2023
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0028378400
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/21/2022
• Supplement Date Received by Manufacturer: 10/12/2022
• Initial Report FDA Received Date: 10/12/2022
• Supplement Report FDA Received Date: 11/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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