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

Model Number	M00572290
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/04/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patient's exact age/date of birth is unknown; however it was reported that the patient was over 18 years old.(b)(4).The device has not been received for analysis; 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 (b)(6) 2018 that an epic biliary stent was implanted to treat a malignant stricture in the mid common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was very tight and was not dilated prior to stent placement.According to the complainant, during procedure, the stent was able to be deployed.However, the delivery system was stuck during withdrawal.The guidewire and the delivery system were pulled out together.While pulling out the delivery system, the inner catheter snapped.A portion of the inner catheter detached and remained within the epic stent.The detached piece of the inner catheter was removed from the patient with forceps.The epic stent remained in the intended location with the patient and an 8x80 wallflex biliary uncovered stent was placed inside the epic biliary stent as a bridge to ensure proper drainage.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
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 stricture in the mid common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was very tight and was not dilated prior to stent placement.According to the complainant, during procedure, the stent was able to be deployed.However, the delivery system was stuck during withdrawal.The guidewire and the delivery system were pulled out together.While pulling out the delivery system, the inner catheter snapped.A portion of the inner catheter detached and remained within the epic stent.The detached piece of the inner catheter was removed from the patient with forceps.The epic stent remained in the intended location with the patient and an 8x80 wallflex biliary uncovered stent was placed inside the epic biliary stent as a bridge to ensure proper drainage.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.
Additional Manufacturer Narrative
An epic biliary stent delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the mid-sheath had a kink.The inner liner shaft showed multiple kinks, and was stretched and separated.The separated ends were jagged indicating the separation was due to tensile overload.No other damage or irregularities were noted to the device.The investigation concluded that the observed failures were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause for this complaint is operational context.A labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.A review of documentation confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.

• Brand Name: EPIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7466518
• Report Number: 3005099803-2018-01265
• Device Sequence Number: 1476417
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• 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
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2018

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 Expiration Date: 11/27/2019
• Device Model Number: M00572290
• Device Lot Number: 0021435098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/03/2018
• Initial Date Received by Manufacturer: 04/04/2018
• Supplement Date Received by Manufacturer: 05/09/2018
• Initial Report FDA Received Date: 04/26/2018
• Supplement Report FDA Received Date: 06/01/2018
• 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