MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION DYNAMIC Y STENT; PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC

Model Number	M00570690
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/23/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant was unable to report the suspect device lot number; therefore, the manufacture and expiration dates are unknown.(b)(4).The complainant indicated that the device was 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 july 24, 2019 that a dynamic y stent was to be used in the central airway during an airway stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent was able to be deployed; however, the posterior membrane of the stent was ripped during removal of the forceps and part of the material was on the forceps.The stent was removed and another stent was used to complete the procedure.There were no patient complications reported as a result of this event.The patient's condition following the procedure was reported to be fine.

• Brand Name: DYNAMIC Y STENT
• Common Device Name: PROSTHESIS, TRACHEAL, EXPANDABLE, POLYMERIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8898675
• Report Number: 3005099803-2019-03969
• Device Sequence Number: 526227
• Product Code: NYT
• UDI-Device Identifier: 08714729764823
• UDI-Public: 08714729764823
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K953593
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/15/2019

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 Model Number: M00570690
• Device Catalogue Number: 7069
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/24/2019
• Initial Report FDA Received Date: 08/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 30 YR
• Patient Weight: 129