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

Model Number	M00570730
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/28/2018
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) 2018 that a wallflex biliary rx partially covered stent was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tortuous.According to the complainant, during the procedure, there was difficulty exiting the guidewire at the guidewire rx port.After several attempts, the guidewire was able to finally pass through the rx port.During stent deployment, the inner catheter broke in half inside the patient, and the stent was not deployed.The wallflex biliary device was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
Event or Problem Description
It was reported to boston scientific corporation on (b)(6) 2018 that a wallflex biliary rx partially covered stent was to be used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2018.Reportedly, the patient¿s anatomy was not tortuous.According to the complainant, during the procedure, there was difficulty exiting the guidewire at the guidewire rx port.After several attempts, the guidewire was able to finally pass through the rx port.During stent deployment, the inner catheter broke in half inside the patient, and the stent was not deployed.The wallflex biliary device was removed from the patient and the procedure was not completed.There were no patient complications reported as a result of this event.The patient's condition was reported to be fine.
Additional Manufacturer Narrative
A wallflex biliary delivery system was received for analysis; the stent was not returned.The delivery system was received in two pieces.Visual examination of the returned device found the clear outer sheath at the distal end was slightly kinked.The inner member was found detached, kinked and damaged.No other issues with the delivery system were noted.The damages noted with the returned device were consistent with excessive force being applied to the delivery system.The investigation concluded that 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.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.

• Brand Name: WALLFLEX¿ BILIARY RX STENT SYSTEM
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC - GALWAY
• MDR Report Key: 7711704
• Report Number: 3005099803-2018-02289
• Device Sequence Number: 2580775
• Product Code: FGE
• UDI-Device Identifier: 08714729759324
• UDI-Public: 08714729759324
• Combination Product (Y/N): N
• Initial Reporter State: NM
• 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,Followup
• Report Date (Section B): 06/29/2018

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: 04/03/2020
• Device Model Number: M00570730
• Device Catalogue Number: 7073
• Device Lot Number: 0021949235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/29/2018
• Supplement Date Received by Manufacturer: 08/07/2018
• Initial Report FDA Received Date: 07/23/2018
• Supplement Report FDA Received Date: 08/30/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1