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

Model Number	M00572280
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Difficult to Advance (2920)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4) captures the reportable event of a partially deployed epic biliary endoscopic stent.The device has been received for analysis.Upon 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) 2021 that an epic biliary endoscopic stent was to be implanted to treat a malignant cholangiocarcinoma in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During insertion, there was difficulty advancing the delivery system through the scope.The stent began to deploy as it advanced from the scope before entering the ampulla.The stent was removed from the patient partially deployed on the delivery system and the procedure was completed with plastic stents.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)(4) 2021 that an epic biliary endoscopic stent was to be implanted to treat a malignant cholangiocarcinoma in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.The patient's anatomy was not tortuous and was not dilated prior to stent placement.During insertion, there was difficulty advancing the delivery system through the scope.The stent began to deploy as it advanced from the scope before entering the ampulla.The stent was removed from the patient partially deployed on the delivery system and the procedure was completed with plastic stents.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem 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.Visual examination was performed and revealed the safety lock was in its original position and the sheath was bent.Microscopic examination was also performed and it was found that the stent is 2 mm deployed and a kink of the outer sheath was noted 20 mm from the distal end.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The investigation concluded that the reported event and the observed failures were most likely due to procedural factors encountered during the procedure.It may be that the interaction of the device with another device caused resistance and contributed to stent partial deployment and sheath kinked as the safety lock was still in the manufactured position.The bend in the sheath suggests that it likely got caught on something which caused the stent to come further out of the sheath.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.

• 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: 12229388
• Report Number: 3005099803-2021-03695
• Device Sequence Number: 3802060
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: 08714729896906
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 09/08/2021

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: 12/14/2022
• Device Model Number: M00572280
• Device Catalogue Number: 7228
• Device Lot Number: 0026512619
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2021
• Initial Date Received by Manufacturer: 07/04/2021
• Supplement Date Received by Manufacturer: 08/12/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 09/08/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1