MAUDE Adverse Event Report: BOSTON SCIENTIFIC - GALWAY WALLFLEX¿ BILIARY RX STENT SYSTEM; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570730
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/07/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device code relates to problem code for the investigation result of outer sheath broken at the outer diameter in the proximal exterior tube ¿ endoscope interface (near the guidewire access sheath).A fully constrained wallflex biliary rx partially covered stent and delivery system were received for analysis.Visual examination of the returned device found the stainless steel tube was actuated beyond its reconstrainment limit, and the inner shaft was found kinked.The outer sheath was broken at the outer diameter: proximal exterior tube - endoscope interface (near the guidewire access sheath).Functional evaluation found that it was not possible to deploy the stent using the delivery system as received, however, it was possible to manually deploy the stent.The stent was measured and was found to be within specifications.No issues were noted with the stent and no other issues were noted with the device.The damages noted to the device were consistent with the application of force during usage.The investigation concluded that the observed failures are likely due to anatomical or procedural factors encountered during the procedure which limited the performance of the device.Therefore, the most probable root cause is operational context.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.A search of the complaint database confirmed that no other similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation that wallflex biliary rx partially covered stent was to be used in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure on (b)(6) 2018.Reportedly, the patient's anatomy was not tortuous and was not dilated prior to stent placement.According to the complaint, during the procedure, the stent failed to deploy.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 fine.Note: this event has been deemed an mdr-reportable event based on investigation results which revealed that the outer sheath was broken at the outer diameter: proximal exterior tube ¿ endoscope interface (at the proximal end of the guidewire access sheath).

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7309484
• Report Number: 3005099803-2018-00580
• Device Sequence Number: 19135700
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/09/2018

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: 09/26/2019
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 21178985
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2018
• Initial Report FDA Received Date: 03/02/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1