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

Model Number	M00565040
Medical Device Problem Codes	Difficult to Advance (2920); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/19/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant reported that the stent remains implanted but the delivery system will be available for returned.However, the device has not been received for analysis.Upon receipt and 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 (b)(6) 2021 that a wallflex colonic stent was implanted to treat a 3cm malignant stricture in the sigmoid colon during a stenting procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous prior to stent placement.During the procedure, the guidewire had difficulty exiting the end of the delivery system inside the patient; however, it was eventually able to exit when the physician pulled the guidewire.Reportedly, resistance was felt when the delivery system was advanced through the scope.The stent was fully deployed in the incorrect location and the physician successfully adjusted the position of the stent using rat tooth forceps.Reportedly, the stent remains implanted and the procedure was completed.There were no patient complications reported 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
• MDR Report Key: 11313100
• Report Number: 3005099803-2021-00467
• Device Sequence Number: 2688769
• Product Code: MQR
• UDI-Device Identifier: 08714729456513
• UDI-Public: 08714729456513
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/05/2022
• Device Model Number: M00565040
• Device Catalogue Number: 6504
• Device Lot Number: 0025812597
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/20/2021
• Initial Report FDA Received Date: 02/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention