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

Model Number	M00572250
Medical Device Problem Codes	Entrapment of Device (1212); Difficult to Remove (1528); Failure to Advance (2524); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device was disposed and will not be returned for evaluation; therefore, a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on june 22, 2021 that an epic biliary endoscopic stent was to be implanted to treat a malignant stricture in the middle of the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp).The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, an epic biliary stent was successfully deployed but since the stricture extended past the stent, the physician decided to place another epic stent to bridge the stricture.The second stent was attempted to be placed through the initial stent, but there was difficulty advancing it through the ampulla due to inflammation.The ampulla was dilated with a cre balloon.The stent was able to be advanced into the correct position and deployment was initiated; however, the thumbwheel stopped working and the stent was only able to be deployed 1 cm.The physician attempted to use the grasp and pull method but was only able to deploy the stent 1.5 cm.The delivery system was difficult to remove and the guidewire got stuck in the epic stent during removal.The stent was removed from the patient partially deployed and a wallflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.

• 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: 12159425
• Report Number: 3005099803-2021-03461
• Device Sequence Number: 4723476
• Product Code: FGE
• UDI-Device Identifier: 08714729896876
• UDI-Public: 08714729896876
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 07/13/2021

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: 08/13/2022
• Device Model Number: M00572250
• Device Catalogue Number: 7225
• Device Lot Number: 0025858552
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/22/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1