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

Model Number	M00572330
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).An epic biliary endoscopic stent and delivery system were received for analysis.The stent was received partially deployed 5cm from the sheath.Visual inspection was performed and multiple kinks were noted along the sheath.Microscopic examination was also performed and it was found that the inner liner was buckled 14.2cm from the tip.No other issues were noted to the stent and delivery system.The investigation concluded that the damages observed on the device may have contributed to the reported event of stent failure to deploy.The kinks along the sheath and the inner liner buckled may be due to resistance when advancing the device along the wire.There is no information that the patient's anatomy may have contributed to the resistance; it may be that procedural factors such as the interaction with another device contributed to resistance which caused the observed damages noted on the device.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary endoscopic stent was to be implanted in the common bile duct during an endoscopic biliary stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the handle moved but stent release could not be started at all.The physician shook and jiggled the delivery system but the stent would not deploy.Reportedly, the stent was fully retracted when it was removed from the patient and a different stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.Note: no further information has been obtained despite good efforts.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the epic biliary endoscopic 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: 11072121
• Report Number: 3005099803-2020-06428
• Device Sequence Number: 2788591
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/24/2020

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: 08/15/2021
• Device Model Number: M00572330
• Device Catalogue Number: 7233
• Device Lot Number: 0024279721
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/08/2020
• Initial Report FDA Received Date: 12/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1