MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY 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	06/30/2018
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)(6) 2018 that a wallflex colonic stent was to be used to treat an omnipresent stenosis in the colon during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient had a history of colon cancer.The patient¿s anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, during procedure, resistance was felt midway and the stent was unable to be deployed.The stent was pulled together with the endoscope, but the stent prematurely deployed inside the patient and shifted from the target stenosis.The stent and delivery system were removed with endoscope and forceps.Reportedly, the procedure was discontinued due to unavailability of another wallflex colonic stent.On (b)(6) 2018, the procedure was continued and was successfully completed with a different device.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 fine.
Additional Manufacturer Narrative
A deployed wallflex colonic stent and a delivery system were received for analysis.Visual examination of the returned device found that the exterior tube was severely kinked at approximately 3 inches from the handle.The stent was measured to be within specifications.There were no issues with the stent noted and no other issues with the delivery system were noted.The damage noted with the returned device is consistent with the excessive force being applied to the delivery system.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure were most probably 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.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 july 2, 2018 that a wallflex colonic stent was to be used to treat an omnipresent stenosis in the colon during a stent placement procedure performed on (b)(6) 2018.Reportedly, the patient had a history of colon cancer.The patient¿s anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, on (b)(6) 2018, during procedure, resistance was felt midway and the stent was unable to be deployed.The stent was pulled together with the endoscope, but the stent prematurely deployed inside the patient and shifted from the target stenosis.The stent and delivery system were removed with endoscope and forceps.Reportedly, the procedure was discontinued due to unavailability of another wallflex colonic stent.On (b)(6) 2018, the procedure was continued and was successfully completed with a different device.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 fine.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7720313
• Report Number: 3005099803-2018-02280
• Device Sequence Number: 1107242
• 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): 07/02/2018

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: 10/07/2018
• Device Model Number: M00565100
• Device Catalogue Number: 6510
• Device Lot Number: 0019812999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2018
• Initial Date Received by Manufacturer: 07/02/2018
• Supplement Date Received by Manufacturer: 08/14/2018
• Initial Report FDA Received Date: 07/25/2018
• Supplement Report FDA Received Date: 09/07/2018
• 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