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

Model Number	M00565110
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been disposed and will not be returned for evaluation; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on january 24, 2017 that a wallflex enteral colonic stent was to be used in a stent placement procedure performed on (b)(6) 2017.According to the complainant, the physician was started to deploy the stent when the stent was stuck could not be fully deployed.The partially deployed stent was removed from the patient and another wallflex colonic stent was used to complete the procedure.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.Despite numerous attempts, boston scientific has been unable obtain additional information regarding the circumstances surrounding this event.Should additional relevant details become available, a supplemental report will be submitted.

• Brand Name: WALLFLEX¿ COLONIC
• Common Device Name: STENT, COLONIC, METALIC, EXPANDABLE
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6332987
• Report Number: 3005099803-2017-00330
• Device Sequence Number: 16546921
• Product Code: MQR
• UDI-Device Identifier: 08714729456582
• UDI-Public: (01)08714729456582(17)20181005(10)0019803469
• Combination Product (Y/N): N
• Initial Reporter State: NM
• Initial Reporter Country: US
• PMA/510(K) Number: K061877
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date (Section B): 01/24/2017

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: 10/05/2018
• Device Model Number: M00565110
• Device Catalogue Number: 6511
• Device Lot Number: 0019803469
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2017
• Initial Report FDA Received Date: 02/15/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1