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

Model Number	M00572240
Medical Device Problem Codes	Difficult to Remove (1528); Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).According to the complainant, the stent remains implanted but the delivery system will be returned.However, the device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2020 an epic biliary endoscopic stent was to be implanted to treat a 3cm malignant recurrent pancreatic head mass in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was altered due to whipple surgery and was not dilated prior to stent placement.According to the complainant, during the procedure, the epic biliary stent was unable to advance into the patient's anatomy due to the guidewire moving.The epic biliary stent was removed and the physician requested a wallflex 8mm x 60mm uncovered biliary stent and attempted to advance into the duct; however, the stent was unable to advance all the way into the duct.Consequently, the stent was removed along with the guidewire.A new hydrajag guidewire was placed and the epic biliary endoscopic stent was re-inserted.This time the stent was able to advance into the duct; however, the stent was deployed slightly proximal to the target region.Reportedly, the delivery system was difficult to remove and after several attempts, the whole scope and delivery catheter were removed from the patient.Reportedly, the stent remains implanted and a second epic biliary stent was implanted percutaneously to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6), 2020 an epic biliary endoscopic stent was to be implanted to treat a 3cm malignant recurrent pancreatic head mass in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2020.Reportedly, the patient's anatomy was altered due to whipple surgery and was not dilated prior to stent placement.According to the complainant, during the procedure, the epic biliary stent was unable to advance into the patient's anatomy due to the guidewire moving.The epic biliary stent was removed and the physician requested a wallflex 8mm x 60mm uncovered biliary stent and attempted to advance into the duct; however, the stent was unable to advance all the way into the duct.Consequently, the stent was removed along with the guidewire.A new hydrajag guidewire was placed and the epic biliary endoscopic stent was re-inserted.This time the stent was able to advance into the duct; however, the stent was deployed sligthly proximal to the target region.Reportedly, the delivery system was difficult to remove and after several attempts, the whole scope and delivery catheter were removed from the patient.Reportedly, the stent remains implanted and a second epic biliary stent was implanted percutaneously to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Medical device problem code a150207 captures the reportable event of delivery system difficult to remove.Block h10: an epic biliary delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found that the sheath was separated at 28cm from the nosecone.The inner liner was separated from the device and was stretched, measuring approximately 45.3 cm long.The tip, distal section of the sheath, and distal section of the inner liner were detached and not returned.Also, multiple kinks were noted along the sheath.No other issues with the delivery system were noted.The investigation found damage that may have contributed to the reported events due to procedural factors.The kinks are most likely from when the device was advanced along the wire and the device was met with some resistance.Stretching of the liner suggests that the device was pulled; it may be that when the device was pulled this contributed to the separation on the sheath and the inner liner.Most likely, the interaction with another device contributed to the resistance which led to the creation of the observational damage to the delivery system.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: EPIC BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11005948
• Report Number: 3005099803-2020-06155
• Device Sequence Number: 3813303
• Product Code: FGE
• UDI-Device Identifier: 08714729896869
• UDI-Public: 08714729896869
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2021

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: 09/18/2022
• Device Model Number: M00572240
• Device Catalogue Number: 7224
• Device Lot Number: 0026041575
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/17/2020
• Initial Date Received by Manufacturer: 11/23/2020
• Supplement Date Received by Manufacturer: 01/14/2021
• Initial Report FDA Received Date: 12/14/2020
• Supplement Report FDA Received Date: 02/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 70 YR
• Patient Weight: 83