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	05/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 two epic biliary endoscopic stents were to be used to treat a malignant hilar biliary obstruction during a bilateral stenting procedure performed on (b)(6) 2022.During the procedure, while trying to deploy the stents side by side, one epic biliary stent was deployed successfully however, the second epic biliary stent did not deploy.The physician tried to pull the catheter but still the second epic biliary stent was unable to release from the delivery system.The second epic biliary stent was removed from the patient undeployed but when the stent was coming out of the scope it was partially deployed.A plastic stent was implanted to complete the procedure.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.
Event or Problem Description
It was reported to boston scientific corporation on may 04, 2022 that two epic biliary endoscopic stents were to be used to treat a malignant hilar biliary obstruction during a bilateral stenting procedure performed on (b)(6) 2022.During the procedure, while trying to deploy the stents side by side, one epic biliary stent was deployed successfully however, the second epic biliary stent did not deploy.The physician tried to pull the catheter but still the second epic biliary stent was unable to release from the delivery system.The second epic biliary stent was removed from the patient undeployed but when the stent was coming out of the scope it was partially deployed.A plastic stent was implanted to complete the procedure.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of axios stent partially deployed.Block h10: an epic biliary endoscopic stent and delivery system were returned for analysis.Visual examination of the returned device found the stent partially deployed.The pull grip was partially retracted and the lock is no longer on the rack.X-ray was performed and kinks were also noted on the outer sheath and nosecone.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.A product labeling review was performed and, from the information available, this device was used per the directions for use (dfu) / product label.Additionally, the dfu warns that "premature removal of the safety lock may result in an unintended deployment of the stent" and "if repositioning of the delivery system is required, reinserting the safety lock will prevent inadvertent deployment." based on the available information, the investigation concluded that the reported event was likely due to the failure to follow the manufacturer's instructions.The lock was not received on the rack which likely contributed to the reported event of stent partial deployment.Furthermore, the kinks noted on the device, possibly occurred during handling for shipment.Therefore, a review and analysis of all available information indicated the most probable cause is failure to follow instructions.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Additional Manufacturer Narrative
Block h6: medical device problem code a15 captures the reportable event of axios stent partially deployed.Block h10: an epic biliary endoscopic stent and delivery system were returned for analysis.Visual examination of the returned device found the stent partially deployed.The pull grip was partially retracted, and the lock is no longer on the rack.X-ray was performed and kinks were also noted on the outer sheath and nosecone.No other problems were noted to the stent and delivery system.The reported event of stent partially deployed was confirmed.A product labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.Additionally, the ifu warns that "premature removal of the safety lock may result in an unintended deployment of the stent" and "if repositioning of the delivery system is required, reinserting the safety lock will prevent inadvertent deployment." the lock was not received on the rack which likely contributed to the reported event of stent partial deployment.Furthermore, the kinks noted on the device, possibly occurred during handling for shipment.Based on the available information, the investigation concluded that the reported events and observed failures were likely due to factors encountered during the procedure.Therefore, the most probable cause is based on the available information is adverse event related to procedure.Block h11: block h6 (device code) has been corrected.
Event or Problem Description
It was reported to boston scientific corporation on may 04, 2022 that two epic biliary endoscopic stents were to be used to treat a malignant hilar biliary obstruction during a bilateral stenting procedure performed on (b)(6) 2022.During the procedure, while trying to deploy the stents side by side, one epic biliary stent was deployed successfully however, the second epic biliary stent did not deploy.The physician tried to pull the catheter but still the second epic biliary stent was unable to release from the delivery system.The second epic biliary stent was removed from the patient undeployed but when the stent was coming out of the scope it was partially deployed.A plastic stent was implanted to complete the procedure.There were no patient complications reported due to this event.The patient condition at the conclusion of the procedure was reported to be stable.

• 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: 14523010
• Report Number: 3005099803-2022-02823
• Device Sequence Number: 6635496
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/16/2022

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: 12/13/2023
• Device Model Number: M00572340
• Device Catalogue Number: 7234
• Device Lot Number: 0028545651
• 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: 05/04/2022
• Supplement Date Received by Manufacturer: 08/10/2022; 10/27/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 08/31/2022; 11/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/13/2021
• 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 Age: 64 YR
• Patient Sex: Female
• Patient Weight: 62 KG