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

Model Number	M00572290
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/22/2018
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.Device component code relates to problem code for the reported event of stent deployed prematurely.The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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) 2018 that an epic biliary stent has been implanted to treat a stenosis in the bile duct due to gall bladder cancer during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during the procedure and subsequent to flushing, an endoscope was inserted inside the patient and a guidewire was placed.The stent was advanced into the target site and was attempted to be deployed by rotating the thumbwheel, however, the outer catheter did not move and the stent could not be deployed.After fully rotating the thumbwheel, the stent still failed to deploy.While removing the delivery system, the stent was suddenly released with about 4 cm of the stent hanging out from the papilla.An argon plasma coagulation was performed to trim the portion of the stent part outside the papilla and the remaining stent was left implanted inside the patient.The patient was reported to be stable and no additional treatment has been performed.
Additional Manufacturer Narrative
An epic biliary and a piece of a deployed epic biliary stent were received for analysis.Visual examination of the returned delivery system identified two kinks along the mid-sheath; the first kink was located at 9 cm from the proximal side of the markerband and the second kink was located just proximal to the markerband.The inner shaft showed multiple kinks.Functional evaluation was performed by rotating the thumbwheel and the outer sheath did pull back as designed.The trimmed part of the stent revealed no other damage or irregularities.No other issues with the device noted.The damages noted with the returned device were attributable to procedural factors.In addition, there was a significant lesion bend according to the complainant, which may have contributed to the difficulty of the stent deploying inside the patient.The investigation concluded that the observed failures and the reported event are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause 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 the device history record (dhr) was performed and confirmed that the device met all material, assembly, and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation on may 22, 2018 that an epic biliary stent has been implanted to treat a stenosis in the bile duct due to gall bladder cancer during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tight and was not dilated prior to stent placement.According to the complainant, during the procedure and subsequent to flushing, an endoscope was inserted inside the patient and a guidewire was placed.The stent was advanced into the target site and was attempted to be deployed by rotating the thumbwheel, however, the outer catheter did not move and the stent could not be deployed.After fully rotating the thumbwheel, the stent still failed to deploy.While removing the delivery system, the stent was suddenly released with about 4 cm of the stent hanging out from the papilla.An argon plasma coagulation was performed to trim the portion of the stent part outside the papilla and the remaining stent was left implanted inside the patient.The patient was reported to be stable and no additional treatment has been performed.

• Brand Name: EPIC
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7598623
• Report Number: 3005099803-2018-01829
• Device Sequence Number: 2029225
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• 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,Followup
• Report Date (Section B): 05/22/2018

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: 09/01/2019
• Device Model Number: M00572290
• Device Lot Number: 0021084598
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2018
• Initial Date Received by Manufacturer: 05/22/2018
• Supplement Date Received by Manufacturer: 06/18/2018
• Initial Report FDA Received Date: 06/13/2018
• Supplement Report FDA Received Date: 07/13/2018
• 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