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

Model Number	M00572300
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/20/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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) 2021 that an epic biliary endoscopic stent was implanted to treat a malignant hilar stricture in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with bilateral 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 stent was deployed successfully; however, there was resistance when the delivery system was attempted to be removed.The physician pulled on the catheter with force in an attempt to remove the delivery system until the physician heard the device break and it was observed endoscopically that the orange transition zone of the inner sheath broke and was stuck inside the cbd.The physician attempted to remove the inner sheath with rat tooth forceps, a snare, and biopsy forceps but all were unsuccessful and the inner sheath remains inside the patient.Reportedly, the original stent remains implanted and the procedure was completed.There were no patient complications as a result of this event.Note: boston scientific has been unable to obtain additional information regarding the event to date, despite good faith efforts.

• 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: 12319100
• Report Number: 3005099803-2021-04141
• Device Sequence Number: 3723303
• Product Code: FGE
• UDI-Device Identifier: 08714729896920
• UDI-Public: 08714729896920
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K171809
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/13/2021

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: 04/08/2023
• Device Model Number: M00572300
• Device Catalogue Number: 7230
• Device Lot Number: 0027104245
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/23/2021
• Initial Report FDA Received Date: 08/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention