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

Model Number	M00572330
Medical Device Problem Codes	Premature Activation (1484); Difficult to Remove (1528); Failure to Advance (2524); Deformation Due to Compressive Stress (2889); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/28/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on september 01, 2020 that an epic biliary stent was to be implanted to treat a stricture in the common bile duct due to cholangiocarcinoma during a biliary stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the delivery system had difficulty crossing the lesion initially.Once the physician was able to cross the stricture the stent was attempted to be deployed; however, the stent failed to deploy even after rotating/turning the thumbwheel for 20 clicks.The device was then attempted to be removed but the stent was not coming out so the scope was pulled back.Upon removal, the stent prematurely deployed in the scope.The procedure was completed with a different device.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 stable.A photo provided by the complainant outside the patient shows the sheath was twisted and buckled.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however it was reported that the patient was over the age of 18.Block h6: problem code 1484 captures the reportable event of stent prematurely deployed.Block h10: an epic biliary endoscopic delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found multiple buckling on the sheath.Multiple snag marks were also noted on the distal end of the middle sheath.The inner liner was separated approximately 2.4cm from the distal end of the middle sheath; the tip and inner liner were not received.No other issues were noted to the delivery system.The buckling indicates there was likely resistance advancing the device.The separation of the inner liner suggests that the tip was likely stuck onto something when the device was attempted to be removed.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.It may be that the anatomy of the patient (tight stricture), limited the performance of the device and contributed to the stent premature deployment.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation on september 01, 2020 that an epic biliary stent was to be implanted to treat a stricture in the common bile duct due to cholangiocarcinoma during a biliary stenting procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tight and was dilated prior to stent placement.According to the complainant, during the procedure, the delivery system had difficulty crossing the lesion initially.Once the physician was able to cross the stricture the stent was attempted to be deployed; however, the stent failed to deploy even after rotating/turning the thumbwheel for 20 clicks.The device was then attempted to be removed but the stent was not coming out so the scope was pulled back.Upon removal, the stent prematurely deployed in the scope.The procedure was completed with a different device.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 stable.A photo provided by the complainant outside the patient shows the sheath was twisted and buckled.

• 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: 10567765
• Report Number: 3005099803-2020-04099
• Device Sequence Number: 3145660
• Product Code: FGE
• UDI-Device Identifier: 08714729896951
• UDI-Public: 08714729896951
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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,Followup
• Report Date (Section B): 12/02/2020

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: 09/04/2021
• Device Model Number: M00572330
• Device Catalogue Number: 7233
• Device Lot Number: 0024382062
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2020
• Initial Date Received by Manufacturer: 09/01/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 09/22/2020
• Supplement Report FDA Received Date: 12/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1