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

Model Number	M00570540
Medical Device Problem Codes	Positioning Failure (1158); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx covered stent and delivery system were returned for analysis.The stent was received partially deployed.Visual examination of the returned device found the clear outer sheath was kinked at the guidewire access sheath (gas) section.The gas ramp was out of position.The inner shaft was kinked out at the gas and was detached at the gas section.The inner sheath was also kinked at a section constrained within the outer sheath.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed manually.The outer diameter of the distal section of the exterior tube (outer sheath) was measured and was found to be within specifications.No other issues with the stent and delivery system were noted.Taking all available information into consideration, the investigation concluded that the reported event and observed failures were likely due to procedural factors which may have limited the performance of the device.Despite efforts, it was not possible to determine whether the guidewire was in place when attempting to deploy the stent.It is possible that this and/or other procedural factors have contributed to the difficult to deploy the stent.Also, the damages noted to the delivery system were likely due to excessive force applied when advancing through the lesion.Therefore, the most probable root cause is adverse event related to the 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 covered stent was to be used to treat a stenosis in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2019.According to the complainant, during the procedure, the stent failed to deploy after advancing through the lesion.The stent was removed from the patient fully covered by the outer sheath.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 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: 9819962
• Report Number: 3005099803-2020-00883
• Device Sequence Number: 1568267
• 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,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/11/2020

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: 03/05/2021
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0023442616
• 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: 02/17/2020
• Initial Report FDA Received Date: 03/11/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 69 YR
• Patient Weight: 69