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

Model Number M00572250

Device Problem Premature Activation (1484)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2022

Event Type  Injury  

Manufacturer Narrative

Date of event: 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 Description

This report pertains to one of two devices used during the same procedure.Refer to manufacturer report # 3005099803-2022-02782 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 mfr.Report # 3005099803-2022-02782).A second epic biliary stent (the subject of this report) 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.

Manufacturer Narrative

Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: medical device problem code a150103 captures the reportable event of stent premature deployment.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.

Event 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 mfr.Report # 3005099803-2022-02782).A second epic biliary stent (the subject of this report) 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.

• Brand Name: EPIC BILIARY
• Type of Device: 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: 14524901
• MDR Text Key: 292838767
• Report Number: 3005099803-2022-02783
• Device Sequence Number: 1
• Product Code: FGE
• UDI-Device Identifier: 08714729896876
• UDI-Public: 08714729896876
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K171809
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 05/04/2022
• Initial Date FDA Received: 05/27/2022
• Supplement Dates Manufacturer Received: 06/14/2022
• Supplement Dates FDA Received: 07/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention