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

Model Number	M00570530
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978); Activation Failure (3270)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/08/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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 partially deployed and the shipping mandrel was returned inside the device.The outer blue sheath was kinked approximately 60 cm from the tip of the delivery system.The stent was inspected and it was noted that the stent did not fully expand and holes were noted on the stent cover.Functional evaluation revealed that it was possible to deploy the stent by actuating the delivery system without resistance.The outer diameter (od) of the stent was measured and the distal measurement was found to be smaller than the od specification.No other issues with the stent and delivery system were noted.The reported even of stent failure to deploy was not confirmed as the stent could be deployed with no resistance.The investigation concluded that the reported event and the observed failures were likely due to factors encountered during the procedure.The kink noted on the outer sheath of the delivery system may have been a result of an excessive force applied to the device during the attempted deployment.It may be how the device was handled or manipulated, the interaction of the device with the scope, and the patient anatomy could have caused the kink in the outer sheath.The number of attempts trying to release the stent could have caused the stent to partially deploy and could have caused holes on the stent cover.The position of the sheath during removal of the patient could have caused the stent failure to expand; therefore, the od distal measurement was found to be smaller than the od specification.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, 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 malignant stenosis in the lower segment of the biliary tract during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the outer sheath felt stuck and the stent failed to deploy.Reportedly, the delivery system failed to unsheathe the stent.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 investigation result which revealed the stent cover was damaged and the stent failed to expand.

• 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: 10346797
• Report Number: 3005099803-2020-03046
• Device Sequence Number: 11586683
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• 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): 07/30/2020

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: 09/02/2021
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0024367215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 07/09/2020
• Initial Report FDA Received Date: 07/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 66