MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY ULTRAFLEX¿ ESOPHAGEAL NG; PROSTHESIS, ESOPHAGEAL

Model Number	M00514210
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/23/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device 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) 2017 that an ultraflex¿ esophageal distal release covered stent was implanted in the esophagus to treat a 5 cm neoplastic cardia stenosis, 39 to 43 cm from the oral fissure, during an esophagogastroduodenoscopy (egd) procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician successfully deployed the ultraflex esophageal stent in the cardia stenosis; however, the distal end of the stent did not fully expand.The physician noted that the stenosis was opened and kept the stent implanted 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 good.

• Brand Name: ULTRAFLEX¿ ESOPHAGEAL NG
• Common Device Name: PROSTHESIS, ESOPHAGEAL
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6503883
• Report Number: 3005099803-2017-01155
• Device Sequence Number: 18834935
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: (01)08714729121206(17)20190119(10)0020182981
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K091816
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/28/2017

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: 01/19/2019
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 0020182981
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/28/2017
• Initial Report FDA Received Date: 04/19/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1