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

Model Number	M00572280
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The exact age of the patient is unknown.However, it was reported the patient was over 18 years.The complainant was unable to provide the suspect device lot number; therefore, the lot expiration and device manufacture dates are unknown.However, the complainant reported that the device was not expired.(b)(4).The complainant indicated that the device is 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 has been implanted in the bile duct to treat a hepatic portal stenosis due to bile duct cancer during a side-by-side (sbs) biliary 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 anterior right hepatic duct (b8) and a second non- bsc guidewire was placed in the left superior hepatic duct (b2).The stent advanced into the anterior right duct (b8) was deployed without issue.The epic biliary stent advanced into the left superior hepatic duct (b2) failed to fully deploy after the thumbwheel was rolled thirty times.An attempt to re-constrain the partially deployed stent was performed, but it was unsuccessful.The handle of the device was then actuated and intentionally deployed the stent but more distal than the desired location.Reportedly, no further treatment was performed however, continuous monitoring of the stent will be observed.There were no complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: EPIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7473220
• Report Number: 3005099803-2018-01187
• Device Sequence Number: 13480844
• Product Code: FGE
• UDI-Device Identifier: 08714729896906
• UDI-Public: 08714729896906
• 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): 04/06/2018

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 Model Number: M00572280
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2018
• Initial Report FDA Received Date: 04/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1