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

Model Number	M00570540
Medical Device Problem Codes	Activation, Positioning or Separation Problem (2906); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/24/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter's address: (b)(6).(b)(4).A wallflex biliary rx covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was returned fully covered and undeployed.The stent was inspected and holes were noted on the stent cover.Functional evaluation was performed and the stent was deployed by actuating the delivery system without resistance.The outer diameter of the stent was measured and was found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent partially deployed was not confirmed.The stent was received fully covered and undeployed.The investigation concluded that the reported event was likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, the interaction of the device with the scope, and/or the patient anatomy, limited the performance of the device and contributed to the stent partially deployed.Additionally, the holes found on the stent cover were likely caused when the physician attempted to deploy the stent.Therefore, a review and analysis of all available information indicated 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.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 used to treat bile duct cancer 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 failed to deploy inside the patient's bile duct.The stent was removed from the patient partially deployed on the delivery system.The procedure was completed with another wallflex biliary stent.There were no patient complications reported 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 an mdr-reportable event based on the 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: 10504480
• Report Number: 3005099803-2020-03775
• Device Sequence Number: 19638844
• Product Code: FGE
• UDI-Device Identifier: 08714729764922
• UDI-Public: 08714729764922
• 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): 09/08/2020

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: 08/11/2021
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0024248983
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/10/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/18/2020
• Initial Report FDA Received Date: 09/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Weight: 60