MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLSTENT RX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00569650
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The complainant indicated that the suspect device remains implanted/ in patient 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 mdr will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallstent biliary rx uncovered stent was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.According to the complainant, after the stent was deployed, it was noticed that the stent was shorter than the labeled length.Reportedly, the stent appeared to be 2 cm in length when it should have been 6 cm.A second wallstent biliary was implanted to piggy back the first stent and the procedure was complete.There were no patient complications as a result of this event.The patient's condition following the procedure was reported to be stable.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 8229042
• Report Number: 3005099803-2018-62434
• Device Sequence Number: 1961469
• Product Code: FGE
• UDI-Device Identifier: 08714729296850
• UDI-Public: 08714729296850
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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): 01/08/2019

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: 03/13/2020
• Device Model Number: M00569650
• Device Catalogue Number: 6965
• Device Lot Number: 0022648752
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/13/2018
• Initial Report FDA Received Date: 01/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1