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

Model Number	M00572290
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/06/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter's city, state/province: (b)(6) (b)(4).The complainant indicated that the stent remains implanted and will not be returned for evaluation; therefore, a problem analysis of the complaint device could not be completed.If any further relevant information is identified, 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 implanted to treat a malignant stenosis in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the epic biliary stent accidentally deployed outside the ampulla.There was no visible damage to the epic biliary stent, which remained implanted.A 6cm wallflex uncovered stent was implanted to bridge the ampulla to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's city, state/province: (b)(6).Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Imdrf impact code f2301 captures the additional intervention of another stent placement.Block h10: an epic biliary delivery system was received for analysis.Visual examination of the returned device found multiple kinks to the inner liner and sheath.A microscopic examination of the remainder of the device presented no other damage or irregularities.The investigation concluded that the reported event of stent premature deployment was related to procedural factors encountered during the procedure.It could be that the interaction of the device with another device contributed to the kinks noted to the inner and outer sheath.Once the sheath becomes damage it may cause the stent to deploy prematurely.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 directions for use (dfu).
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that an epic biliary endoscopic stent was implanted to treat a malignant stenosis in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on june 06, 2022.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.During the procedure, the epic biliary stent accidentally deployed outside the ampulla.There was no visible damage to the epic biliary stent, which remained implanted.A 6cm wallflex uncovered stent was implanted to bridge the ampulla 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
• 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: 14858708
• Report Number: 3005099803-2022-03479
• Device Sequence Number: 17345331
• Product Code: FGE
• UDI-Device Identifier: 08714729896913
• UDI-Public: 08714729896913
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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
• Report Date (Section B): 09/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/10/2023
• Device Model Number: M00572290
• Device Catalogue Number: 7229
• Device Lot Number: 0028532978
• 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: 06/06/2022
• Supplement Date Received by Manufacturer: 08/27/2022
• Initial Report FDA Received Date: 06/29/2022
• Supplement Report FDA Received Date: 09/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/10/2021
• 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
• Outcome Attributed to Adverse Event: Required Intervention; Required Intervention
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 85 KG
• Patient Race: White