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

Model Number	M00570650
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be implanted to treat a stricture during a endoscopic retrograde cholangiopancreatography (ercp) with biliary metal stent placement procedure performed on (b)(6) 2024.Prior to the procedure, the stent deployed as it was being loaded.Another wallflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be implanted to treat a stricture during a endoscopic retrograde cholangiopancreatography (ercp) with biliary metal stent placement procedure performed on (b)(6) 2024.Prior to the procedure, the stent deployed as it was being loaded.Another wallflex biliary stent was used to complete the procedure.There were no patient complications as a result of this event.Additional information received on january 14, 2025: it was reported that the wallflex biliary stent was to be implanted in the common bile duct.
Additional Manufacturer Narrative
Block b5 has been updated with the additional information received on january 14, 2025.Block h6: imdrf device code a150103 captures the reportable event of stent premature deployment.

• Brand Name: WALLFLEX 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: 21060443
• Report Number: 3005099803-2024-06783
• Device Sequence Number: 8023043
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/06/2025

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: 05/03/2026
• Device Model Number: M00570650
• Device Catalogue Number: M00570650
• Device Lot Number: 0033959548
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2024
• Supplement Date Received by Manufacturer: 01/14/2025
• Initial Report FDA Received Date: 01/02/2025
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/03/2024
• 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: Prefer Not To Disclose