MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ COLONIC; STENT, COLONIC, METALIC, EXPANDABLE

Model Number	M00565100
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/10/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.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 (b)(4) 2018 that a wallflex colonic stent was to be used to treat a stricture in the colon caused by a tumor during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tight.According to the complainant, during procedure, the stent was able to be deployed however, it failed to expand in the intended placement area.The stent was then removed from the patient and noticed the stent had expanded outside the patient's body.The procedure was completed with a 9cm wallflex colonic stent.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 good.
Additional Manufacturer Narrative
A deployed wallflex colonic stent and delivery system were received for analysis.Visual examination of the returned device found a severe kink on the stainless steel tube.The outer sheath was also kinked approximately 6 inches from the exterior tube handle.The stent was measured to be within specifications.No other issues with the device were noted.The damages noted with the returned device were consistent with excessive force applied and device manipulation during used.Given the event description and the condition of the returned device, the investigation concluded that the reported failure was likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.A labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly and performance specifications at the time of release for distribution.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex colonic stent was to be used to treat a stricture in the colon caused by a tumor during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tight.According to the complainant, during procedure, the stent was able to be deployed however, it failed to expand in the intended placement area.The stent was then removed from the patient and noticed the stent had expanded outside the patient's body.The procedure was completed with a 9cm wallflex colonic stent.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 good.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7485524
• Report Number: 3005099803-2018-01270
• Device Sequence Number: 1716733
• Product Code: MQR
• UDI-Device Identifier: 08714729456575
• UDI-Public: 08714729456575
• Combination Product (Y/N): N
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2018

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: 04/29/2018
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 19203418
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/18/2018
• Initial Date Received by Manufacturer: 04/11/2018
• Supplement Date Received by Manufacturer: 05/30/2018
• Initial Report FDA Received Date: 05/03/2018
• Supplement Report FDA Received Date: 06/26/2018
• 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