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

Model Number	M00570650
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event was approximated to be (b)(6) 2018, as no specific event date was reported problem code (b)(4) captures the reportable investigation finding of outer sheath detached/broken at the outer diameter: proximal exterior tube- endoscope interface (proximal end of the guidewire access sheath).A fully constrained wallflex biliary rx uncovered 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 the outer sheath was detached/broken at the outer diameter: proximal exterior tube - endoscope interface (proximal end of the guidewire access sheath).There were three kinks identified in the inner member at the guidewire access sheath section.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was deployed by manually gripping the outer sheath and pulling the tip distally.No other issues were noted to the stent and delivery system.The damages noted with the returned device were consistent with the application of excessive force during use.The force used was likely due to resistance encountered during procedure, probably due to difficult patient anatomies such as stenosis or tortuosity resulting in the inability to deploy the stent.It is possible that factors and/or conditions related to procedure during the use of the device could have affected its performance and its intended purpose, leading to the reported event.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 specifications at the time of release for distribution.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.According to the complainant, during the procedure, when the tech had fully deployed the handle of the wallflex biliary stent remained fully covered by the outer sheath.The stent failed to deploy.The procedure was completed with another wallflex biliary stent.There were no patient complications reported as a result of this event.Note: this event has been deemed a mdr-reportable event based on investigation results, which revealed that the outer sheath was detached/broken at the outer diameter: proximal exterior tube-endoscope interface (proximal end of the guidewire access sheath).

• 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: 8161087
• Report Number: 3005099803-2018-61912
• Device Sequence Number: 2126541
• Product Code: FGE
• UDI-Device Identifier: 08714729758150
• UDI-Public: 08714729758150
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 12/13/2018

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: 02/22/2020
• Device Model Number: M00570650
• Device Catalogue Number: 7065
• Device Lot Number: 0021776610
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/19/2018
• Initial Report FDA Received Date: 12/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1