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

Model Number	M00565100
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on november 30, 2020 that a wallflex colonic stent was to be implanted in the colon during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, outside the patient, the stent prematurely deployed inside the scope when the delivery system was inserted into the scope.Another wallflex colonic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Event or Problem Description
It was reported to boston scientific corporation on november 30, 2020 that a wallflex colonic stent was to be implanted in the colon during a procedure performed on (b)(6) 2020.According to the complainant, during the procedure, outside the patient, the stent prematurely deployed inside the scope when the delivery system was inserted into the scope.Another wallflex colonic stent was implanted to complete the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 1484 captures the reportable event of stent prematurely deployed.Block h10: a wallflex colonic stent delivery system was received for analysis; the stent was not returned.Visual examination found the outer clear sheath and the inner sheath were returned kinked and the handle was returned slightly bent.No other issues were noted to the delivery system.The reported event of stent premature deployment could not be confirmed.This failure occurred during the procedure and it is not possible to replicate in the laboratory of analysis.Taking all available information into consideration, the investigation concluded that the reported events and the observed failures were likely due to procedural factors encountered during the procedure.It may be that the technique used by the user when the device was inserted through the scope could have caused the kinks in the outer and inner sheath and resulted to premature deployment of the stent.Additionally, how the device was handled or manipulated during the procedure could have caused the handle to be slightly bent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.A labeling review was performed, and from the information available, this device was used per the instructions for use (ifu) / product label.

• Brand Name: WALLFLEX COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 11070099
• Report Number: 3005099803-2020-06294
• Device Sequence Number: 2788586
• Product Code: MQR
• UDI-Device Identifier: 08714729456575
• UDI-Public: 08714729456575
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2021

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: 09/29/2022
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0026097730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Initial Date Received by Manufacturer: 11/30/2020
• Supplement Date Received by Manufacturer: 12/23/2020
• Initial Report FDA Received Date: 12/23/2020
• Supplement Report FDA Received Date: 01/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1