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

Model Number	H965431100
Medical Device Problem Codes	Mechanical Problem (1384); Material Deformation (2976); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/27/2019
Type of Reportable Event	Serious Injury
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) 2019 that a wallstent biliary partially covered stent was to be used to treat a 3cm periampullary carcinoma in the common bile duct (cbd) during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.Reportedly, the patient's ampulla was tight and the rest of the cbd was dilated.According to the complainant, during the procedure, after the stent had been partially deployed the physician wanted to reposition the stent but it could not be re-constrained.The stent ws deployed inside the cbd but not on the target site.A dormia basket was used to try to reposition the stent but the entire stent came out from the cbd.The dormia basket was used to remove the stent from the patient and another wallstent biliary was used to complete the procedure.Reportedly, the proximal part of the stent was deformed by being grasped by the dormia basket during removal.There were no patient complications reported as a result of this event and the patient was in stable condition following the procedure.

• 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: 8550940
• Report Number: 3005099803-2019-02201
• Device Sequence Number: 11373567
• Product Code: FGE
• UDI-Device Identifier: 08714729317937
• UDI-Public: 08714729317937
• Combination Product (Y/N): N
• Initial Reporter Country: BG
• PMA/510(K) Number: K000308
• 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): 04/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 11/27/2020
• Device Model Number: H965431100
• Device Catalogue Number: 3110
• Device Lot Number: 0023002242
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/04/2019
• Initial Report FDA Received Date: 04/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 65 YR
• Patient Weight: 48