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

Model Number	M00565060
Medical Device Problem Codes	Entrapment of Device (1212); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through fluoroscopy; however, post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked and the wallflex enteral stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on december 01, 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through flouroscopy even though two colonic stents were in situ from previous procedures, and visibility through the scope was difficult.Post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked, and the wallflex enteral colonic stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.Additional information received on december 22, 2022: no additional stent was placed, and the procedure was not completed.
Additional Manufacturer Narrative
Blocks b5 and h6 (impact codes) have been updated with additional information received on december 22, 2022.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h11: block b5 has been corrected.
Additional Manufacturer Narrative
Blocks b5 and h6 (impact codes) have been updated with additional information received on january 03, 2023.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2022 that a wallflex enteral colonic stent was to be implanted to treat a malignant stricture during a colonic stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tortuous.During the procedure, the physician had seen and confirmed stent deployment through flouroscopy even though two colonic stents were in situ from previous procedures, and visibility through the scope was difficult.Post stent deployment, when the scope was brought for reprocessing cleaning process, it was noted that the scope was blocked, and the wallflex enteral colonic stent was found deployed inside the scope.It is unknown how was the stent removed from the scope.There were no patient complications reported as a result of this event.**additional information received on december 22, 2022** no additional stent was placed, and the procedure was not completed.**additional information received on january 03, 2023** on an unknown date, the patient was brought back for a repeat procedure using another wallflex enteral colonic stent and the procedure was completed successfully.

• 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: 16019203
• Report Number: 3005099803-2022-07625
• Device Sequence Number: 17616270
• Product Code: MQR
• UDI-Device Identifier: 08714729456537
• UDI-Public: 08714729456537
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Followup
• Report Date (Section B): 01/18/2023

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 Model Number: M00565060
• Device Catalogue Number: 6506
• 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: 12/01/2022
• Supplement Date Received by Manufacturer: 12/01/2022; 01/03/2023
• Initial Report FDA Received Date: 12/20/2022
• Supplement Report FDA Received Date: 12/23/2022; 01/18/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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