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

Model Number	M00570650
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	06/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx uncovered stent and delivery system were returned for analysis.Visual examination of the returned device found the stent was received fully covered by the outer sheath and undeployed.The outer sheath was stretched out in the guidewire access sheath (gas) section and the gas ramp was found lifted.The inner sheath was found kinking out of the gas section and was separated.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 cutting the tip distally.The outer diameter (od) of the stent was measured and was found to be within specifications.No other issues with the stent and delivery system were noted.The reported event of stent failure to deploy was confirmed.The damages noted on the delivery system may have been a result of excessive force applied to the device during use.Taking all available information into consideration, the investigation concluded that the reported event of stent failure to deploy and the observed failures were 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 tortuous anatomy of the patient could have caused the physician to apply force, which limited the performance of the device and contributed to the failure reported of stent failure to deploy and the observed damages on the inner and outer sheath.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 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 uncovered stent was to be implanted in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was not dilated prior to stent placement and the patient had a tortuous anatomy.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 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 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: 10420103
• Report Number: 3005099803-2020-03350
• Device Sequence Number: 19848596
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/18/2020

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: 02/17/2021
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0023363072
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/24/2020
• Initial Report FDA Received Date: 08/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1