MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION ULTRAFLEX ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514250
Medical Device Problem Codes	Break (1069); Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/11/2018
Type of Reportable Event	Malfunction
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 an ultraflex esophageal proximal release covered stent was to be used during an esophageal stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, "the stent was half opened and thread was released".The procedure was completed with another device.There were no patient complications reported as a result of this event.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
Event or Problem Description
It was reported to boston scientific corporation on september 12, 2018 that an ultraflex esophageal proximal release covered stent was to be used during an esophageal stent placement procedure performed on september 11, 2018.According to the complainant, during the procedure, "the stent was half opened and thread was released".The procedure was completed with another device.There were no patient complications reported as a result of this event.Despite numerous attempts boston scientific has been unable obtain additional information regarding the circumstances surrounding this event to date.Should additional relevant details become available a supplemental report will be submitted.
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A partially deployed ultraflex esophageal ng proximal release stent and delivery system were returned for analysis.Visual examination of the returned device identified no issues with the stent and delivery system.Functional evaluation revealed that it was possible to deploy the stent with no resistance by pulling the finger ring.The stent was measured to be within specifications.The report that the stent was partially deployed was confirmed; the stent was received partially deployed.The investigation concluded that procedural factors encountered during the procedure, or the technique used by the physician, could have affected the device performance and its integrity contributing to the failure reported.Therefore, the most probable root cause is adverse event related to procedure.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 released for distribution.

• Brand Name: ULTRAFLEX ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 7954105
• Report Number: 3005099803-2018-60813
• Device Sequence Number: 203829
• Product Code: ESW
• UDI-Device Identifier: 08714729716112
• UDI-Public: 08714729716112
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K091816
• 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): 12/07/2018

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: 06/28/2020
• Device Model Number: M00514250
• Device Catalogue Number: 1425
• Device Lot Number: 0022319126
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Initial Date Received by Manufacturer: 09/12/2018
• Supplement Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 10/10/2018
• Supplement Report FDA Received Date: 12/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1