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

Model Number	M00570660
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/31/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient's exact age is unknown; however it was reported that the patient was over the age of 18.(b)(4).The device has been received for analysis; however the evaluation has not been completed.Therefore, the cause of the reported malfunction has not been determined.Upon completion of the failure analysis of the complaint device, if there is any further relevant information from that review, a supplemental medwatch will be filed.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 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 on (b)(6) 2018.According to the complainant, during the initial stent placement, the stent was dislodged and fell into the intestinal tract.The stent was removed with forceps, and another wallflex biliary stent was placed to complete the procedure.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 stable.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 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 on (b)(6) 2018.According to the complainant, during the initial stent placement, the stent was dislodged and fell into the intestinal tract.The stent was removed with forceps, and another wallflex biliary stent was placed to complete the procedure.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 stable.
Additional Manufacturer Narrative
A wallflex biliary rx delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer sheath was kinked at the distal section and at the end of stiffning mandrel.The inner member was also kinked at the distal section.No other issues with the device were noted.The damages noted with the returned device were consistent with the excessive force being applied to the delivery system during the procedure.Taking all available information into consideration, the investigation concluded that the reported event and the observed failures were 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.Labeling review was performed, and from the information available this device was used per the directions for use (dfu)/product label.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.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7648561
• Report Number: 3005099803-2018-02050
• Device Sequence Number: 16557188
• Product Code: FGE
• UDI-Device Identifier: 08714729759287
• UDI-Public: 08714729759287
• Combination Product (Y/N): N
• Initial Reporter Country: CN
• 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,Followup
• Report Date (Section B): 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 08/28/2019
• Device Model Number: M00570660
• Device Catalogue Number: 7066
• Device Lot Number: 21062753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 07/20/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/10/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention