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

Model Number	M00570540
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The returned wallflex biliary stent was analyzed, and a visual inspection noted that stent was returned fully covered and undeployed.Holes in the stent cover were noted.A microscopic evaluation confirmed the holes in the stent cover.A function evaluation noted that it was necessary to deploy the stent manually by gripping the outer sheath and pulling the tip distally because some resistance was felt.A dimensional evaluation noted that the outer diameter of the stent was measured within specification.No other issues with the device were noted.The reported event of stent failure to deploy was confirmed as the device was returned undeployed and there was resistance felt when deploying the stent manually.Additionally, holes in the stent cover were confirmed.Most likely, factors encountered during the procedure and/or the interaction with the scope, and the patient's anatomy could have caused the physician to use excessive force try to deploy the stent, ultimately resulting in failure of the stent to deploy.The holes in the stent cover could be a result of when the physician attempted to deploy the stent during the procedure.Therefore, a review and analysis of all available information indicated that the most probable root cause is adverse event related to 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, 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 covered wallflex biliary stent was to be implanted to treat a 3 centimeter sized cancer in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent failed to deploy and stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with another covered 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.This event has been deemed a reportable event based on the investigation finding of stent cover damage.

• 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: 10079189
• Report Number: 3005099803-2020-01993
• Device Sequence Number: 2823389
• 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,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/12/2021
• Device Model Number: M00570540
• Device Catalogue Number: 7054
• Device Lot Number: 0023949149
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/30/2020
• Initial Report FDA Received Date: 05/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR
• Patient Weight: 65