MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX DUODENAL; STENT,METALLIC,EXPANDABLE,DUODENAL

Model Number	M00565010
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/10/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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) 2018 that a wallflex duodenal stent was to be used to treat a short and malignant duodenal neoplastic stenosis during an esophagogastroduodenoscopy (egd) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the delivery system broke distal to the stent, before the stent was released.The device was removed and another wallflex duodenal stent was implanted to complete the procedure.There were no patient complication reported as a result of this event.

• Brand Name: WALLFLEX DUODENAL
• Common Device Name: STENT,METALLIC,EXPANDABLE,DUODENAL
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8223949
• Report Number: 3005099803-2019-00011
• Device Sequence Number: 16212512
• Product Code: MUM
• UDI-Device Identifier: 08714729456483
• UDI-Public: 08714729456483
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K062750
• 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): 01/07/2019

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: 07/15/2020
• Device Model Number: M00565010
• Device Catalogue Number: 6501
• Device Lot Number: 0022378418
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 01/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1