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

Model Number	M00570540
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/19/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block 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 (b)(6) 2023, that a wallflex biliary rx covered stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, shortening was too severe.There were no reported patient complications as a result of this event.Note: as it is unclear from the information available what the failure was and attempts to obtain details regarding the event have been unsuccessful, the reported event of "shortening was too severe" will be assessed as "stent material deformation," and an additional device was used to remove the stent from the patient.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2023, that a wallflex biliary rx covered stent was to be implanted during a procedure performed on (b)(6) 2023.During the procedure, shortening was too severe.There were no reported patient complications as a result of this event.Note: as it is unclear from the information available what the failure was and attempts to obtain details regarding the event have been unsuccessful, the reported event of "shortening was too severe" will be assessed as "stent material deformation.".
Additional Manufacturer Narrative
Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.

• 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: 17098403
• Report Number: 3005099803-2023-03091
• Device Sequence Number: 18064872
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/16/2023

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: 11/15/2024
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0030553316
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/23/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 06/09/2023
• Supplement Report FDA Received Date: 06/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• 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