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

Model Number	M00513850
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been received for analysis.Upon receipt and completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2019 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a malignant stricture in the esophagus during an esophageal stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was unable to be fully deployed as the deployment suture was knotted.The partially deployed stent was removed and another ultraflex esophageal stent was placed to complete the procedure.There were no were patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: problem code 2906 captures the reportable event of proximal released stent partially deployed.Block h10: an ultraflex esophageal ng proximal release covered stent and delivery system were received for analysis; the deployment suture was not returned.Visual examination of the returned device found the stent was received fully deployed off the delivery system and expanded.No damage or issues noted to the stent or delivery system.As there was no issue with the returned device, the reported event could not be confirmed.Therefore, the most probable root cause for the complaint event is no problem detected.A review of the device history record (dhr) confirmed that the device met all material, assembly and product specifications at the time of release to distribution.
Event or Problem Description
It was reported to boston scientific corporation on march 2, 2019 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a malignant stricture in the esophagus during an esophageal stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was unable to be fully deployed as the deployment suture was knotted.The partially deployed stent was removed and another ultraflex esophageal stent was placed to complete the procedure.There were no were patient complications reported as a result of this event.

• 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: 8453829
• Report Number: 3005099803-2019-01458
• Device Sequence Number: 2765492
• Product Code: ESW
• UDI-Device Identifier: 08714729716075
• UDI-Public: 08714729716075
• 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): 06/11/2019

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 Expiration Date: 10/17/2020
• Device Model Number: M00513850
• Device Catalogue Number: 1385
• Device Lot Number: 0022810953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2019
• Initial Date Received by Manufacturer: 03/02/2019
• Supplement Date Received by Manufacturer: 05/17/2019
• Initial Report FDA Received Date: 03/26/2019
• Supplement Report FDA Received Date: 06/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1