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

Model Number	M00572300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.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) 2021 that an epic biliary endoscopic stent was to be implanted stent-in-stent in the common bile duct to treat a bile duct cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the physician had difficulty inserting the guidewire through the stent.Subsequently, slight resistance was felt when inserting the delivery system into the common bile duct.Reportedly, the delivery system was advanced with force and the stent partially deployed about 1 cm.The stent was unable to advance further into the bile duct and the stent was removed from the patient partially deployed on the delivery system.Another epic biliary endoscopic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of an epic biliary endoscopic stent partially deployed.Block h10: an epic biliary endoscopic stent and delivery system were received for analysis.The stent was received partially deployed.Visual examination of the returned device found multiple kinks along the sheath.The lock for the pull rack was missing.The stent was deformed and stretched.Microscopic examination revealed the tip was damaged.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.The kinks and damage to the tip are most likely from when the device was advanced along the wire and the device was met with some resistance.Stretching of the stent suggest that the device was damaged during removal.The investigation concluded that the reported events and the observed failures were likely due to procedural factors encountered during the procedure such as the interactions with another device as the most likely cause for the resistance.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.
Event or Problem Description
It was reported to boston scientific corporation on january 27, 2021 that an epic biliary endoscopic stent was to be implanted stent-in-stent in the common bile duct to treat a bile duct cancer during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the physician had difficulty inserting the guidewire through the stent.Subsequently, slight resistance was felt when inserting the delivery system into the common bile duct.Reportedly, the delivery system was advanced with force and the stent partially deployed about 1 cm.The stent was unable to advance further into the bile duct and the stent was removed from the patient partially deployed on the delivery system.Another epic biliary endoscopic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.

• 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: 11338933
• Report Number: 3005099803-2021-00579
• Device Sequence Number: 14323534
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/09/2021

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: 09/16/2021
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0024444956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Initial Date Received by Manufacturer: 01/27/2021
• Supplement Date Received by Manufacturer: 02/17/2021
• Initial Report FDA Received Date: 02/17/2021
• Supplement Report FDA Received Date: 03/09/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1