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

Model Number	M00570510
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(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) 2017 that a wallflex biliary rx covered stent was implanted in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2017.Reportedly, the patient¿s anatomy was normal and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent.However, when the delivery system was removed, the tapered tip of the catheter got caught on the stent and separated from the catheter.The physician left the detached piece of the catheter inside the patient and completed 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 fine.
Additional Manufacturer Narrative
A fully deployed wallflex biliary rx covered stent delivery system was returned for analysis; the stent was not returned.Visual analysis of the returned device found that the inner shaft was detached.No other issues were noted with the device.Device analysis determined that the condition of the returned device was consistent with the reported event.The noted damages to the returned device were consistent with excessive force being applied during device usage and are likely due to anatomical or procedural factors, which limited the performance of the device.Therefore, a review and analysis of all available information indicated that 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 similar complaints exist for the specified lot.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2017 that a wallflex biliary rx covered stent was implanted in the common bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) procedure on (b)(6) 2017.Reportedly, the patient¿s anatomy was normal and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician was able to deploy the stent.However, when the delivery system was removed, the tapered tip of the catheter got caught on the stent and separated from the catheter.The physician left the detached piece of the catheter inside the patient and completed 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 fine.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7148926
• Report Number: 3005099803-2017-03891
• Device Sequence Number: 1238208
• Product Code: FGE
• UDI-Device Identifier: 08714729764892
• UDI-Public: 08714729764892
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2017
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2017

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: 11/07/2018
• Device Model Number: M00570510
• Device Catalogue Number: 7051
• Device Lot Number: 19934991
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2017
• Initial Date Received by Manufacturer: 12/07/2017
• Supplement Date Received by Manufacturer: 01/05/2018
• Initial Report FDA Received Date: 12/27/2017
• Supplement Report FDA Received Date: 01/26/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1