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

Model Number	M00570520
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	09/15/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A wallflex biliary rx covered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection was performed and it was found that the outer blue sheath was kinked approximately 46cm from the tip of the delivery system.The outer sheath was stretched out in the guidewire access sheath (gas) section.The stent cover was damaged with holes.During functional inspection, the stent was deployed with no resistance by actuating the delivery system.The outer diameter (od) of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy was not confirmed; the stent was able to deploy without any issues during functional inspection.The investigation concluded that the damages encountered in the delivery system were likely caused when the physician attempted to deploy the stent during the procedure.Additionally, the stent cover was damaged with holes; however, there is not sufficient information about what could be the cause for this failure.Therefore, an investigation is in place to address this problem.The product investigation findings do not lead to a clear conclusion about the cause of the reported event and observed failure; therefore, the most probable cause is cause not established.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 instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation a wallflex biliary rx covered stent was to be implanted to treat a stenosis in the bile duct during a stenting procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was unable to deploy inside the patient.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 the investigation results which revealed that the stent cover was damaged with holes.

• 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: 10943403
• Report Number: 3005099803-2020-05787
• Device Sequence Number: 3419378
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: 08714729764908
• 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): 12/03/2020

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: 02/10/2022
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0025189067
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/06/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 12/04/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 41 YR
• Patient Weight: 70