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

Model Number	M00565050
Medical Device Problem Code	Positioning Failure (1158)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used to treat a 70mm malignant colonic obstruction during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tight.During the procedure, the wallflex enteral colonic stent was unable to deploy.The wallflex enteral colonic stent was fully covered by the outer sheath on the delivery system when it was removed from the patient.The procedure was not completed due to device availability.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
(b)(6).(b)(4).
Additional Manufacturer Narrative
Block h6: impact code f1001 is being used to capture the reportable issue of aborted/canceled procedure.Block h10: a wallflex enteral colonic stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection found the outer clear sheath kinked.Functional inspection revealed that it was possible to deploy the stent with no resistance by actuating the delivery system (slide the handle back along the stainless steel tube).No other issues were noted to the stent and delivery system.The investigation concluded that the procedural factors such as lesion characteristics, handling of the device, the technique used by the physician, and normal procedural difficulties encountered during the procedure could have limited the performance of the device and contributed to the observed event of sheath kinked.However, the reported event of stent failure to deploy was not confirmed as the stent was able to deploy during functional inspection.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was not used in accordance with the directions for use (dfu) / product label.Block h11: correction to block e1 (initial reporter address 1, initial reporter address 2, and city) based on the review of the complaint.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex enteral colonic stent was used to treat a 70mm malignant colonic obstruction during a stent placement procedure performed on (b)(6) 2022.The patient's anatomy was tight.During the procedure, the wallflex enteral colonic stent was unable to deploy.The wallflex enteral colonic stent was fully covered by the outer sheath on the delivery system when it was removed from the patient.The procedure was not completed due to device availability.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: 15755751
• Report Number: 3005099803-2022-06506
• Device Sequence Number: 20424182
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/28/2022

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: 01/19/2023
• Device Model Number: M00565050
• Device Catalogue Number: 6505
• Device Lot Number: 0026654491
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 10/19/2022
• Supplement Date Received by Manufacturer: 12/06/2022
• Initial Report FDA Received Date: 11/08/2022
• Supplement Report FDA Received Date: 12/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/19/2021
• 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 Age: 75 YR
• Patient Sex: Female
• Patient Weight: 62 KG