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

Model Number	M00572240
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however, it was reported that the patient was over the age of 18.The complainant was unable to provide the suspect device lot number.Therefore, the manufacture and expiration dates are unknown.However, the complainant stated that the device was used prior to the expiration date.(b)(4).The complainant indicated that the device remains implanted 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that an epic biliary stent was implanted to treat a malignant biliary stenosis during a side-by-side (sbs) stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, a guidewire was placed in the right hepatic duct and a second non-bsc guidewire was passed towards the left hepatic duct.However, only 2-3 cm of the guidewire was able to advance 2-3 cm from the hepatic portal.The stent advanced into the right duct was deployed without issue.There was difficulty advancing the epic biliary stent into the left hepatic duct.The stent was removed and then placed again within the left duct.The stent was able to be successfully deployed but when the guidewire was attempted to be removed, resistance was encountered.Additional force was exerted, the guidewire was forcibly pulled and became entangled with the stent.Subsequently, an angiographic catheter was inserted to unravel the entangled part of the guidewire but it was not unraveled and was not removed.The physician attempted to remove the guidewire and stent by using grasping forceps, but when it was pulled 2 cm out of position the stent could no longer be removed.Reportedly, the procedure was temporarily ended and an emergency operation was considered.The physician decided to endoscopically cut the guidewire.A 3 mm balloon was advanced along the guidewire towards the entangled part and both were forcibly pulled, about 10 cm from the tip of the guidewire was detached and remained inside the patient.There is no planned schedule for removal of the detached guidewire.The physician was comfortable leaving the stent where it was implanted and there was no effect on drainage.In the physician¿s assessment, the necessity of drainage in the left hepatic duct was low or not needed because the liver was atrophied.The patient's current condition was reported to have "no problem.".

• Brand Name: EPIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7370987
• Report Number: 3005099803-2018-00916
• Device Sequence Number: 19106038
• Product Code: FGE
• UDI-Device Identifier: 08714729896869
• UDI-Public: 08714729896869
• Combination Product (Y/N): N
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00572240
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/05/2018
• Initial Report FDA Received Date: 03/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention