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

Model Number	M00514210
Medical Device Problem Code	Activation, Positioning or Separation Problem (2906)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The complainant indicated that the device has been 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 november 14, 2016 that an ultraflex esophageal distal release stent was to be used to treat a 10cm malignant stricture in the mid esophagus during an esophagogastroduodenoscopy with stent placement procedure performed on (b)(6) 2016.According to the complainant, during the procedure, the physician started deploying the stent when the deployment suture got tangled with the distal end of the stent.The partially deployed stent was removed from the patient and the procedure was completed using another ultraflex esophageal distal release stent.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 - GALWAY
• MDR Report Key: 6152232
• Report Number: 3005099803-2016-03698
• Device Sequence Number: 13643926
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: (01)08714729121206(17)20180708(10)19456857
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 11/14/2016

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: 07/08/2018
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 19456857
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/14/2016
• Initial Report FDA Received Date: 12/07/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1