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

Model Number	M00565040
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/01/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.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 that a wallflex enteral colonic stent was used during a stent placement procedure performed on an unknown date.During the procedure, the stent was deployed; however, when the delivery system was removed, it was noted that the stent was hanging out of the rectum instead of being in the bowel.The patient's condition following the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used during a stent placement procedure performed on an unknown date.During the procedure, the stent was deployed; however, when the delivery system was removed, it was noted that the stent was hanging out of the rectum instead of being in the bowel.The patient's condition following the procedure was reported to be stable.Note: no further information has been obtained despite good faith efforts.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.Block h10: a wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully expanded and deployed.Visual inspection observed no problems with the stent and delivery system.Product analysis did not confirm the reported event of stent positioning issue because this occurred during the procedure and is not possible to replicate in the laboratory of analysis.The device meets all the manufacturing specifications required, passed all controls and inspections, and no abnormalities were reported during the assembly process.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.Additionally, stent positioning issue is noted within the ifu as a potential adverse event associated with the use of the device.Therefore, a review and analysis of all available information indicated the most probable cause is known inherent risk of device.

• 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: 18165653
• Report Number: 3005099803-2023-06191
• Device Sequence Number: 6646685
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• 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: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/29/2024

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: 10/19/2024
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0030382787
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/26/2023
• Supplement Date Received by Manufacturer: 01/09/2024
• Initial Report FDA Received Date: 11/17/2023
• Supplement Report FDA Received Date: 01/29/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/20/2022
• 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