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

Model Number	M00570740
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary stent and delivery system were received for analysis.The stent was received fully covered and undeployed.A visual examination of the returned device found the stent cover was damaged (holes).The outer sheath was detached from the guidewire access sleeve (gas) section.The inner sheath was kinked in several sections.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by gripping the outer sheath and pulling the tip distally.The outer diameter (od) and length of the stent 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 failure to deploy and sheath break were confirmed.Functional evaluation revealed that it was not possible to deploy the fully covered undeployed stent as it was received and the outer sheath was found deatched from the gas section.Taking all available information into consideration, the investigation concluded that the reported events and observed failures may have been related to procedural factors.It may be the technique used by the user and/or the interaction of the device with the scope could have caused the physician to feel resistance and use excessive force, which limited the performance of the device and contributed to the reported events and the observed failures.Additionally, the stent cover damage may be from the attempts to deploy the stent.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to the procedure.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 instructions for use (ifu)/ product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be implanted to treat a malignant stenosis in the bile duct during a stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not tortous and was not dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy and the outer sheath broke.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 fine.Note: this event has been deemed mdr reportable event based on the investigation finding of 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: 11130603
• Report Number: 3005099803-2020-06399
• Device Sequence Number: 11596793
• Product Code: FGE
• UDI-Device Identifier: 08714729759331
• UDI-Public: 08714729759331
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K140630
• 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): 01/07/2021

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: 05/12/2022
• Device Model Number: M00570740
• Device Catalogue Number: 7074
• Device Lot Number: 0025508383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 01/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1