MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY STENTS; BILIARY STENT SYSTEM FOR BENIGN STRICTURES

Model Number	M00570350
Medical Device Problem Code	Appropriate Device Problem Term/Code Not Available (3191)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/03/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 (b)(6) 2017 that a wallflex biliary rx fully covered rmv stent was to be used in the common bile duct to treat a 3cm malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with metal stent placement procedure performed on (b)(6) 2017.Reportedly, the patient¿s anatomy was tight but was not dilated prior to stent placement.According to the complainant, during the procedure, the physician had difficulty deploying the stent.It was noted that the stent appeared longer than the length indicated on the package.The stent was fully reconstrained when it was removed from the patient 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 fine.

• Brand Name: WALLFLEX¿ BILIARY STENTS
• Common Device Name: BILIARY STENT SYSTEM FOR BENIGN STRICTURES
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 6747306
• Report Number: 3005099803-2017-02294
• Device Sequence Number: 919905
• Product Code: PNB
• UDI-Device Identifier: 08714729953166
• UDI-Public: (01)08714729953166(17)20180810(10)0019578975
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: DEN150040
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/05/2017

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: 08/10/2018
• Device Model Number: M00570350
• Device Lot Number: 0019578975
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2017
• Initial Report FDA Received Date: 07/27/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1