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

Model Number	M00572340
Medical Device Problem Codes	Positioning Failure (1158); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/18/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an epic biliary stent was used to treat a malignant hilar stricture during a bilateral stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to deploy.The stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with only one epic biliary stent being placed.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the epic biliary stent was partially deployed.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a15 captures the investigation findings of stent partially deployed.Block h10: an epic biliary stent and delivery system were received for analysis.The stent was received partially deployed on the delivery system.Visual inspection found the sheath and the inner sheath kinked at more than one location.Functional inspection revealed that it was not possible to deploy the stent due to the sheath being damaged.No other problems were noted with the stent and delivery system.The reported event of stent failure to deploy was not confirmed.It is most likely that the device may have encountered difficult patient anatomy which can lead to an extrinsic compression.Applying excessive force when attempting to position the device could have contributed to the observed events of inner sheath and sheath kinked.Furthermore, the kinking of the device could have resulted in the deployment failure which is consistent with the results of the product analysis.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Additional Manufacturer Narrative
Blocks b5, h6 (device codes), and h10 have been updated with additional information received on september 08, 2023.Block h6: imdrf device code a15 captures the reportable event of stent partially deployed.Block h10: an epic biliary stent and delivery system were received for analysis.The stent was received partially deployed on the delivery system.Visual inspection found the sheath and the inner sheath kinked at more than one location.Functional inspection revealed that it was not possible to deploy the stent due to the sheath being damaged.No other problems were noted with the stent and delivery system.Product analysis confirmed the reported event of stent partially deployed.It is most likely that the device may have encountered difficult patient anatomy which can lead to an extrinsic compression.Applying excessive force when attempting to position the device could have contributed to the observed events of inner sheath and sheath kinked.Furthermore, the kinking of the device could have resulted in the stent being partially deployed which is consistent with the results of the product analysis.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A product labeling review identified that the 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 stent was used to treat a malignant hilar stricture during a bilateral stent placement procedure performed on (b)(6) 2023.The patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the stent was unable to deploy.The stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with only one epic biliary stent being placed.There were no patient complications reported as a result of this event.Note: this event has been deemed an mdr-reportable event based on the investigation results which revealed that the epic biliary stent was partially deployed.Additional information received on september 08, 2023 while removing the delivery system, the 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
• 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: 17710585
• Report Number: 3005099803-2023-04674
• Device Sequence Number: 2226244
• 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
• Report Date (Section B): 09/25/2023

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: 08/15/2024
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0029961879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/16/2023
• Supplement Date Received by Manufacturer: 09/08/2023
• Initial Report FDA Received Date: 09/08/2023
• Supplement Report FDA Received Date: 09/25/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2022
• 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