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

Model Number M00565050

Device Problems Entrapment of Device (1212); Premature Activation (1484); Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/05/2024

Event Type  malfunction  

Manufacturer Narrative

Block h6: imdrf device code a150103 captures the reportable event of stent prematurely deployed.

Event 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.

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 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
• Type of Device: 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
• MDR Text Key: 333972840
• Report Number: 3005099803-2024-00088
• Device Sequence Number: 1
• Product Code: MQR
• UDI-Device Identifier: 08714729456520
• UDI-Public: 08714729456520
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K061877
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/05/2024
• Initial Date FDA Received: 01/29/2024
• Supplement Dates Manufacturer Received: 03/11/2024
• Supplement Dates FDA Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/30/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1