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

Model Number	M00570520
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx covered stent and delivery system were received for analysis.The stent was received fully covered by the outer sheath and undeployed.Visual examination of the returned device found the stent cover was damaged with holes.Functional examination was performed and the stent was deployed without resistance by actuating the delivery system.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent failed to deployed cannot be confirmed as the stent was deployed without problems.Additionally, the stent cover was damaged with holes; however, there is not sufficient information about what could be the cause for this failure.Therefore, an investigation is in place to address this problem.The product investigation findings did not lead to a clear conclusion about the cause of the reported event and the observed failure; therefore, the most probable cause is cause not established.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing a labeling review was performed and, from the information available, there is no information that this device was used in a manner inconsistent with the directions for use (dfu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the common bile duct during a stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent failed to deploy.The procedure was completed with another wallflex 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.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the stent cover was damaged (holes).

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10943441
• Report Number: 3005099803-2020-05788
• Device Sequence Number: 3419379
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/03/2020

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: 02/10/2022
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0025189067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Weight: 70