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

Model Number	M00572250
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Event date: approximated based on the date the manufacturer became aware of the event.(b)(4).The complainant indicated that the device was disposed 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
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02782 and 33005099803-2022-02783 for the associated device information.It was reported to boston scientific corporation on (b)(6) 2022 that two epic biliary stents were to be used to treat a hilar stricture during an interventional radiology (ir) and endoscopic retrograde cholangiopancreatography (ercp) procedure performed with stent placement procedure performed on an unknown date.During the procedure, the first epic biliary stent was deployed successfully (the subject of this report).A second epic biliary stent (the subject of mfr.Report # 33005099803-2022-02783) was attempted to be used; however, the stent prematurely deployed and disrupted the first stent.Both stents were removed from the patient and the procedure was completed via an alternative method or device.There were no patient complications reported 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.
Event or Problem Description
Note: this report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02782 and 33005099803-2022-02783 for the associated device information.It was reported to boston scientific corporation on may 04, 2022 that two epic biliary stents were to be used to treat a hilar stricture during an interventional radiology (ir) and endoscopic retrograde cholangiopancreatography (ercp) procedure performed with stent placement procedure performed on an unknown date.During the procedure, the first epic biliary stent was deployed successfully (the subject of this report).A second epic biliary stent (the subject of mfr.Report # 33005099803-2022-02783) was attempted to be used; however, the stent prematurely deployed and disrupted the first stent.Both stents were removed from the patient and the procedure was completed via an alternative method or device.There were no patient complications reported 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.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a1502 captures the reportable event of stent positioning issue.Block h10: the complainant indicated that the device was disposed 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.Block h11: block h6 (impact codes) has been corrected.

• 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: 14523121
• Report Number: 3005099803-2022-02782
• Device Sequence Number: 6635532
• Product Code: FGE
• UDI-Device Identifier: 08714729896876
• UDI-Public: 08714729896876
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

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: 04/08/2023
• Device Model Number: M00572250
• Device Catalogue Number: 7225
• Device Lot Number: 0027104242
• Was Device Available for Evaluation?: No
• 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: 06/14/2022
• Initial Report FDA Received Date: 05/27/2022
• Supplement Report FDA Received Date: 07/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown