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

Model Number	M00570730
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907); Material Deformation (2976); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2019 as no specific event date was reported.(b)(4).A wallflex biliary rx partially covered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received undeployed and was fully covered by the outer sheath.The clear outer sheath at the gas was noted to be damaged.The blue outer sheath was kinked and stretched out.The outer sheath was broken at the stiffening mandrel and the inner sheath was detached from the rest of the component.The inner shaft was kinked and at this point was found exiting at the guidewire access port.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed manually by gripping the outer sheath and pulling the tip distally.The stent was measured to be within specifications.No other damages were noted with the stent and delivery system.The damages noted to the delivery system are consistent with excessive force applied to the device during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were most likely due to procedural factors, such as handling of the device, the technique used by the user, and normal procedural difficulties encountered during the procedure, 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.A 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 wallflex biliary rx partially covered stent was to be used during a procedure performed on an unknown date.According to the complainant, during the procedure, there was a problem firing the wallflex biliary material.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.Photos of the complaint device were received and upon review the outer sheath was damaged and the inner shaft was kinked.Note: this event has been deemed a mdr-reportable event based on investigation results which revealed that the inner shaft/ sheath was detached/separated.

• 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: 9795340
• Report Number: 3005099803-2020-00743
• Device Sequence Number: 2574180
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 03/05/2020

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: 03/27/2021
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0023556805
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 03/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1