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

Model Number	M00572340
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age was not reported; however, the patient was reported to be over the age of 18.Impact code: (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 medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on march 11, 2022 that an epic biliary endoscopic stent was to be implanted in the bile duct to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was fully covered by the outer sheath when it was removed from the patient.A percutaneous transhepatic biliary drainage (ptbd) was performed the next day to treat the patient.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1 (initial reporter address 1, city, state, zip/post code) has been updated with additional information received on april 02, 2022.Block a2: the patient's exact age was not reported; however, the patient was reported to be over the age of 18.Block e1: the initial reporter's address is (b)(6) block h6: impact code f05 is being used to capture the reportable issue of aborted/cancelled procedure.Conclusion code d17 is being used in lieu of an adequate conclusion code for device not returned.Block h10: the device has not been received for analysis.Upon receipt and completion of the problem 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), 2022 that an epic biliary endoscopic stent was to be implanted in the bile duct to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was fully covered by the outer sheath when it was removed from the patient.A percutaneous transhepatic biliary drainage (ptbd) was performed the next day to treat the patient.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an epic biliary endoscopic stent was to be implanted in the bile duct to treat a hilar cholangiocarcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to be deployed.The stent was fully covered by the outer sheath when it was removed from the patient.A percutaneous transhepatic biliary drainage (ptbd) was performed the next day to treat the patient.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: the patient's exact age was not reported; however, the patient was reported to be over the age of 18.Block e1: the initial reporter's address is (b)(6).Block h6: impact code f05 is being used to capture the reportable issue of aborted/cancelled procedure.Block h10: an epic biliary endoscopic stent and delivery system were returned for analysis inside the shipping tube.The rack was fully extended but the stent was confirmed to be under the sheath in the manufactured position.Visual examination of the returned device found multiple kinks on the outer sheath.The outer sheath and the stainless steel ribbon band were also buckled.Microscopic examination was performed and found no additional damages to the device.No other issues were noted to the stent and delivery system.Product analysis confirmed the reported event of stent failure to deploy.The damages noted were most likely due to procedural factors that were encountered such as the interaction with another device which resulted in the sheath becoming kinked.Furthermore, the kinks noted on the sheath may have occurred when the device was advanced along the wire and resistance was met.The damages noted were most likely due to factors that were encountered during the procedure.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.

• Brand Name: EPIC BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13978379
• Report Number: 3005099803-2022-01722
• Device Sequence Number: 5872201
• Product Code: FGE
• UDI-Device Identifier: 08714729896968
• UDI-Public: 08714729896968
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/15/2022

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: 09/04/2022
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0025970931
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/11/2022
• Supplement Date Received by Manufacturer: 04/02/2022; 05/24/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/25/2022; 06/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/04/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Male