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

Model Number	M00513840
Medical Device Problem Codes	Failure to Advance (2524); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).(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 (b)(6) 2019 that an ultraflex esophageal ng proximal release covered stent was to be used to treat a malignant stricture in the mid to distal esophagus during a stenting procedure performed on (b)(6) 2019.Reportedly, the patient's anatomy was tight, navigation of the scope was not possible and stricture was dilated using savery dilator to up to 12 cm prior to stent placement procedure.The endoscope was then able to be passed and the stricture was measured to be from 27 cm point on the endoscope to the 33 cm point.According to the complainant, during the procedure, the endoscope was placed at the side to view the stent, the catheter was positioned at 25 cm and the stent was released.However, following deployment it was noted that the catheter had kinked at the distal end of the stricture and did not cross the lesion.Reportedly, the stent was deployed proximal to the intended location.The stent was removed with rat tooth forceps and another ultraflex esophageal 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 stable.

• 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: 9084160
• Report Number: 3005099803-2019-04588
• Device Sequence Number: 16786247
• Product Code: ESW
• UDI-Device Identifier: 08714729716099
• UDI-Public: 08714729716099
• 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
• Report Date (Section B): 09/18/2019

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: 03/27/2021
• Device Model Number: M00513840
• Device Catalogue Number: 1384
• Device Lot Number: 0023555414
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/27/2019
• Initial Report FDA Received Date: 09/18/2019
• 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