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

Model Number	M00570530
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/09/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: imdrf device code a0406 captures the reportable event of stent material deformation.
Event or Problem Description
It was reported to boston scientific corporation on june 11, 2023, that a wallflex biliary rx covered stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, the stent "shortening was too severe".There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fine.

• 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: 17210910
• Report Number: 3005099803-2023-03511
• Device Sequence Number: 6333415
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 06/27/2023

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: 04/18/2024
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0029249231
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/11/2023
• Initial Report FDA Received Date: 06/27/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/19/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown