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

Model Number	M00565050
Medical Device Problem Codes	Entrapment of Device (1212); Premature Activation (1484); Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted to treat an intestinal obstruction in the intestinal tract during a colonic stent implantation procedure performed on (b)(6) 2024.During the procedure, the guidewire was advanced; however, it got stuck.The nurse attempted to remove the guidewire but encountered difficulty in doing so.The guidewire was eventually removed; however, the stent prematurely deployed outside the patient.Another wallflex enteral stent was used to complete the procedure.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 stable.
Additional Manufacturer Narrative
Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.Block h10: a wallflex enteral stent and delivery system were returned for analysis.The stent was received fully deployed and expanded.Visual examination of the returned device found the stainless-steel bent.Functional inspection was performed, the guidewire was able to be released from the delivery system without problems.The guidewire was also attempted to be inserted through the device and the guidewire was able to exit the guidewire access sheath (gas) ramp as expected.No other problems were noted with the stent and delivery system.The investigation concluded that the observed problem of stainless-steel bent was likely due to factors encountered during the procedure.It may be that lesion characteristics, handling of the device and/or the technique used by the physician (force applied), limited the performance of the device and contributed to the observed problem.The reported event of stent premature deployment cannot be confirmed as this event occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Based on the available information, there is not enough information to confirm the reported event of stent premature deployment; therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was implanted to treat an intestinal obstruction in the intestinal tract during a colonic stent implantation procedure performed on (b)(6) 2024.During the procedure, the guidewire was advanced; however, it got stuck.The nurse attempted to remove the guidewire but encountered difficulty in doing so.The guidewire was eventually removed; however, the stent prematurely deployed outside the patient.Another wallflex enteral stent was used to complete the procedure.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 stable.

• 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: 18596383
• Report Number: 3005099803-2024-00088
• Device Sequence Number: 12793038
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 03/28/2024

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: 01/29/2025
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0030944250
• 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: 01/05/2024
• Supplement Date Received by Manufacturer: 03/11/2024
• Initial Report FDA Received Date: 01/29/2024
• Supplement Report FDA Received Date: 03/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/30/2023
• 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: Unknown