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

Model Number	M00570730
Medical Device Problem Codes	Break (1069); Positioning Failure (1158); Difficult to Advance (2920)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/17/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).A fully constrained wallflex biliary rx partially covered stent and delivery system were returned for analysis.The stent was received fully covered by the outer sheath.Visual examination of the returned device found that the outer sheath was detached/broken at the outer diameter: proximal exterior tube - endoscope interface (proximal end of the gas section).Also, a kink in the outer sheath at the end of the stiffening mandrel, and in the inner member near the proximal end of the gas (guidewire access sheath) section were identified.The gas ramp was found kinked which is a result of the use of the device.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by gripping the outer sheath and pulling the tip distally.A test 0.035" guidewire was inserted through the delivery system from the distal tip of the catheter and it did not exit at the guidewire access port due to the kink at the gas ramp.No other issues were noted with the stent and delivery system.The damages noted with the returned device were consistent with the application of excessive force during use.Taking all available information into consideration, the investigation concluded that the observed failures and the reported event were likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable cause is adverse event related to procedure.A review of the device history record was performed and confirmed that this device met all material, assembly and performance specifications at the time of release similar.
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 4cm malignant bile duct mass during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient's anatomy was not dilated prior to stent placement.According to the complainant, during the procedure, the guidewire had a lot of trouble exiting the rx port of the delivery system.During stent deployment, a loud "pop" sound was heard, and the stent would not deploy.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 as a result of this event.The patient condition following the procedure was reported to be fine.Note: the event has been deemed a mdr reportable event based on the investigation results which revealed that the outer sheath was broken at the outer diameter: proximal exterior tube - endoscope interface (proximal end of the guidewire access sheath section).

• 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: 7969067
• Report Number: 3005099803-2018-60854
• Device Sequence Number: 1572579
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• 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): 10/16/2018

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: 04/25/2020
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0022045325
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/21/2018
• Initial Report FDA Received Date: 10/16/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1