MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLSTENT¿ RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00569720
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the device remains implanted 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 wallstent biliary rx partially covered stent was implanted to treat a 6 cm malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography with stent placement procedure performed on (b)(6) 2018.Reportedly, the patients anatomy was very tight and was dilated prior to stent placement.According to the complainant, during the procedure, the stent was able to be deployed.However, when the stent was viewed by the physician following deployment it was noted that the end of the stent was not 0.5 to 1 cm outside the common bile duct as intended.The stent positioning marker had been noted to be correct prior to full deployment.The stent remained 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 stable.

• Brand Name: WALLSTENT¿ RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7648696
• Report Number: 3005099803-2018-02112
• Device Sequence Number: 1652339
• Product Code: FGE
• UDI-Device Identifier: 08714729296928
• UDI-Public: 08714729296928
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K012752
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/07/2018

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: 05/18/2019
• Device Model Number: M00569720
• Device Catalogue Number: 6972
• Device Lot Number: 21401052
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/07/2018
• Initial Report FDA Received Date: 06/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR