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

Model Number	M00572330
Medical Device Problem Codes	Difficult or Delayed Positioning (1157); Entrapment of Device (1212); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The returned epic biliary stent was analyzed, and a visual evaluation noted that the stent was received deployed outside the delivery system.The stent was stretched and slightly deformed.Multiple kinks in the inner liner were noted and the sheath was buckled in two separate places.A microscopic examination revealed that the inner liner is prolapsed 14.1cm from the tip.No other issues with the device were noted.The reported event was confirmed.The analysis of the device found damage that could have contributed to the failure to deploy in the patient.The kinks in the shaft were most likely caused by the handling of the device when it was sent back for analysis.Buckling to the sheath suggests there was difficulty advancing to the lesion.Prolapsing of the inner liner indicates there was difficulty deploying the stent.Tortuosity can potentially cause issues; therefore, it is likely that the patient's anatomy contributed to the resistance which led to the creation of the damages.The damage to the stent likely occurred when the new stent was passed down the working channel.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to patient condition.
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was to be implanted to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.It was reported that the anatomy was dilated prior to the stent placement procedure and the patient had a slightly tortuous anatomy.According to the complainant, during the procedure, the physician lined up the ro marker to deploy the stent in the bile duct; however, the stent fully deployed in the scope.The stent was removed from the scope when another stent was passed down the working channel of the scope.The procedure was completed with a wallflex 10x80 stent.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of stent deformation.

• 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: 9885566
• Report Number: 3005099803-2020-01337
• Device Sequence Number: 742293
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/26/2020

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: 10/16/2021
• Device Model Number: M00572330
• Device Catalogue Number: 57233
• Device Lot Number: 0024614322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/06/2020
• Initial Report FDA Received Date: 03/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1