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

Model Number	H965431100
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/21/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patients exact age was not reported, however the patient was reported to be over the age of 18.(b)(6).(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), 2020 that a wallstent biliary partially covered stent had been implanted to treat an approximately 2cm periampullary carcinoma during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2020.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent was deployed; however, the stent migrated distally after deployment.The stent remains implanted and the procedure was completed with another wallstent biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10148221
• Report Number: 3005099803-2020-02287
• Device Sequence Number: 11306912
• Product Code: FGE
• UDI-Device Identifier: 08714729317937
• UDI-Public: 08714729317937
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2020

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: 08/07/2021
• Device Model Number: H965431100
• Device Catalogue Number: 3110
• Device Lot Number: 0024235816
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/22/2020
• Initial Report FDA Received Date: 06/12/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1