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

Model Number	M00532210
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/30/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of stent failure to curl.This event was reported by the sales representative.The health care facility is: (b)(6).
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) for stone removal procedure in the common bile duct, performed on (b)(6), 2023.During the procedure, the physician noted that the stent pigtail was not curled enough and it may slip out from the common bile duct.The advanix biliary stent was removed, and a non-boston scientific device was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a23 captures the reportable event of stent failure to curl.This event was reported by the sales representative.The health care facility is: (b)(6) hospital pte ltd (b)(6) block h11: block h6 device code has been corrected to capture the updated as reported code of device shelf life exceeded.
Event or Problem Description
It was reported to boston scientific that an advanix biliary stent was used during an endoscopic retrograde cholangiopancreatography (ercp) for stone removal procedure in the common bile duct, performed on (b)(6) 2023.During the procedure, the physician noted that the stent pigtail was not curled enough and it may slip out from the common bile duct.The advanix biliary stent was removed, and a non-boston scientific device was opened and used to successfully complete the procedure.There were no patient complications reported as a result of this event.

• Brand Name: ADVANIX 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; 780 brookside drive; spencer IN 47460
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 17795190
• Report Number: 3005099803-2023-05054
• Device Sequence Number: 6981722
• Product Code: FGE
• UDI-Device Identifier: 08714729786993
• UDI-Public: 08714729786993
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K101786
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2023

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: 04/15/2023
• Device Model Number: M00532210
• Device Catalogue Number: 3221
• Device Lot Number: 0027145417
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/30/2023
• Supplement Date Received by Manufacturer: 09/27/2023
• Initial Report FDA Received Date: 09/21/2023
• Supplement Report FDA Received Date: 10/20/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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 Sex: Unknown