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

Model Number	M00570730
Medical Device Problem Codes	Break (1069); Positioning Failure (1158)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).A fully constrained wallflex biliary rx partially covered stent and delivery system were returned for analysis.The stent was received undeployed and 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 was a kink identified in the inner member.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 investigation concluded that the observed failures and the reported event were likely due to procedural factors such as handling of the device, the technique of the user, and normal procedural difficulties encountered during the procedure could have affected the device performance and its integrity contributing to the failure experienced by the user during the procedure.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 partially covered stent was to be used to treat a malignant stricture in the common bile duct due to pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.According to the complainant, during the procedure, the outer sheath of the catheter would not unsheathe and the stent would not deploy.The device was removed and a 10 x 60 wallflex biliary fully covered stent was placed to complete the procedure.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: 8212881
• Report Number: 3005099803-2018-62363
• Device Sequence Number: 1960854
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 01/03/2019

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: 08/19/2020
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0022534098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/10/2018
• Initial Report FDA Received Date: 01/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1