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

Model Number	M00572290
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to (b)(6) 2021 as no specific event date was reported.(b)(4).An epic biliary endoscopic stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination was performed and it was found that the sheath was buckled.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy is likely due to something restricting the sheaths ability to move.The observed failure of sheath buckled is most likely due to the device meeting some resistance during advancement of the delivery system.The investigation concluded that the observed failures of stent partially deployed and sheath buckled may have contributed to the deployment issue.Procedural factors such as the interactions with another device likely contributed to the resistance which led to the creation of the damages.Once the sheath is damaged, it can contribute to deployment failure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.A labeling review was performed and from the information available, this device was used per the directions for use (dfu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During the procedure, the stent was unable to deploy.The stent was removed from the patient and another epic biliary stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent was partially deployed.

• 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: 11657007
• Report Number: 3005099803-2021-01654
• Device Sequence Number: 3682948
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 04/13/2021

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: 06/02/2022
• Device Model Number: M00572290
• Device Catalogue Number: 7229
• Device Lot Number: 0025554017
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/23/2021
• Initial Report FDA Received Date: 04/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1