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

Model Number	M00513800
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	12/31/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Initial reporter title: team leader endoscopy unit.(b)(4).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 january 06, 2020 that an ultraflex esophageal ng proximal release uncovered stent was implanted in the oesophagus during a stent placement procedure performed on (b)(6) 2019.According to the complainant, on (b)(6) 2019, it was felt that the stent did not stay fully open.The patient was re-scoped and it was confirmed that the stent failed to expand and was not fully open.The physician tried to expand the stent using a dilatation balloon catheter and then it opened with the use of rat tooth forceps.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 okay.

• 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: 9639729
• Report Number: 3005099803-2020-00132
• Device Sequence Number: 11490057
• Product Code: ESW
• UDI-Device Identifier: 08714729716174
• UDI-Public: 08714729716174
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/28/2020

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: 03/05/2021
• Device Model Number: M00513800
• Device Catalogue Number: 1380
• Device Lot Number: 0023444782
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/06/2020
• Initial Report FDA Received Date: 01/28/2020
• 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