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

Model Number	H965431200
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/17/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallstent biliary partially covered stent and delivery system were returned for analysis.The stent was received fully covered by the outer sheath.Visual examination of the returned device found the stainless steel tube handle was kinked.The outer sheath was found detached from the valve body of the handle and the blue outer sheath was found kinked in several sections.The stent wires were found out of the clear outer sheath near the leading radiopaque marker band on the delivery system.Functional evaluation revealed that it was not possible to deploy the stent due to the condition of the returned device.No other damages with the stent and delivery system were noted.The damages noted with the returned device were likely due to procedural factors, such as the interaction of the device with the scope, the patient anatomy, and the amount of force applied during the attempt deployment, which limited the performance of the device.Therefore, the most probable cause is adverse event related to procedure.A review of the device history record (dhr) was performed and confirmed that this device met all material, assembly, and performance specifications at the time of release for distribution.Labeling review was performed, and from the information available, this device was used per the directions for use (dfu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary partially covered stent was to be used to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with metal stenting procedure performed on (b)(6), 2019.Reportedly, patient's anatomy was not tortuous but the stricture was tight causing obstruction.The stricture was dilated prior to stent placement.According to the complainant, during the procedure, force was applied to deploy the stent, but the stent failed to deploy.The stent was removed from the patient fully covered by the outer sheath.The procedure was completed with another wallstent biliary.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent wires punctured the clear outer sheath of the delivery system.

• 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: 9875368
• Report Number: 3005099803-2020-01187
• Device Sequence Number: 16939794
• Product Code: FGE
• UDI-Device Identifier: 08714729229902
• UDI-Public: 08714729229902
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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): 03/24/2020

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: 11/01/2020
• Device Model Number: H965431200
• Device Catalogue Number: 3120
• Device Lot Number: 0022880226
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/20/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 03/24/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 58 YR
• Patient Weight: 52