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

Model Number	M00570720
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fully constrained wallflex biliary rx partially covered stent and delivery system were received for analysis.The stent was received fully covered by the outer sheath.Visual examination of the returned device found the clear outer sheath at the distal end was punctured and the stent wire was exposed.The outer sheath at the end of the stiffening mandrel, and the clear sheath at the distal end were found kinked.The transition between the clear distal section and the blue proximal section was buckled.The stainless steel tube and the trailing handle were detached from the stiffening mandrel.Functional evaluation revealed that the stent could not be deployed using the delivery system as received, as a result of the stainless steel tube detached; however, it was possible to deploy the stent by gripping the outer sheath and pulling the tip distally.No other issues with the stent and delivery system were noted.The damages noted with the returned device are consistent with the application of excessive force during use.This could also have contributed to the reported event of stent deployment failure.The investigation concluded that the device might have encountered difficult patient anatomies, such as tortuosity, during the procedure which may have resulted in exposed stent wire.Therefore, the most probable root 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 specification at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx partially covered stent was to be used to treat a malignant stricture in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was tortuous.According to the complainant, during the procedure, the stent was stuck and it was unable to be deployed.The stent was fully covered by the outer sheath when removed from the patient.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.This event has been deemed an mdr reportable event based on investigation result which revealed the outer sheath at the distal end was punctured and the stent wire was exposed.

• 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: 8185497
• Report Number: 3005099803-2018-62081
• Device Sequence Number: 16505652
• Product Code: FGE
• UDI-Device Identifier: 08714729759317
• UDI-Public: 08714729759317
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 12/20/2018

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: 02/08/2020
• Device Model Number: M00570720
• Device Catalogue Number: 7072
• Device Lot Number: 0021719073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/17/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/27/2018
• Initial Report FDA Received Date: 12/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1