MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565060
Medical Device Problem Codes	Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/27/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex colonic stent was to be implanted in the colon to treat a colon cancer during a colonic stent placement procedure performed on (b)(6) 2024.During preparation, it was noticed that the stent was kinked, and the stent was not used in the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6).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 that a wallflex colonic stent was to be implanted in the colon to treat a colon cancer during a colonic stent placement procedure performed on (b)(6) 2024.During preparation, it was noticed that the stent was kinked, and the stent was not used in the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter address: (b)(6); reported here as the initial reporter address exceeded character limit for the designated field.Block h6: imdrf device code a0406 captures the reportable event of stent material deformation.Block h11: a wallflex colonic stent was received for analysis.Visual examination of the returned device found the stent fully covered and undeployed, and the stainless-steel handle was kinked.Functional inspection was performed by actuating the delivery system (slide the handle back along the stainless-steel tube), and the stent was deployed without problems.No other problems were noted with the stent and delivery system.Product analysis did not confirm the reported event of stent material deformation.The observed problem of stainless steel kinked, mostly occurred due to procedural factors such as lesion characteristics, handling of the device, the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problem.There is no indication of what the customer reported because there were no damages found as the stent was inspected.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• 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: 19377790
• Report Number: 3005099803-2024-02301
• Device Sequence Number: 12629070
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K061877
• 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): 12/30/2024

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: 05/21/2025
• Device Model Number: M00565060
• Device Catalogue Number: 6506
• Device Lot Number: 0031663693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/27/2024
• Supplement Date Received by Manufacturer: 12/04/2024
• Initial Report FDA Received Date: 05/22/2024
• Supplement Report FDA Received Date: 12/30/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/22/2023
• 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: Female