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	02/14/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device has been contaminated 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
Note: this manufacturer report pertains to one of two devices used in the same procedure.Refer to manufacturer report # 3005099803-2017-00605 and 3005099803-2017-00606 for the other associated device information.It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex esophageal fully covered rmv and an ultraflex esophageal distal release stents were to be used to treat a malignant stricture in the esophagus during an esophageal metallic stenting procedure performed on (b)(6) 2017.According to the complainant, during the procedure, the physician was able to fully deploy the wallflex esophageal stent (the subject to mfr report # 3005099803-2017-00605) inside the patient; however, the stent failed to expand.The physician removed the stent using rat tooth forceps and deployed the ultraflex esophageal stent (the subject to mfr report # 3005099803-2017-00606) but the same issue occurred.The ultraflex esophageal stent was removed using rat tooth forceps and the procedure was completed with a different device.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 - GALWAY
• MDR Report Key: 6385103
• Report Number: 3005099803-2017-00606
• Device Sequence Number: 19047889
• Product Code: ESW
• UDI-Device Identifier: 08714729121206
• UDI-Public: (01)08714729121206(17)20180825(10)19637848
• 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): 02/14/2017

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: 08/25/2018
• Device Model Number: M00514210
• Device Catalogue Number: 1421
• Device Lot Number: 19637848
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/14/2017
• Initial Report FDA Received Date: 03/07/2017
• 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