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

Model Number	M00570520
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/21/2017
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 july 24, 2017 that a wallflex biliary rx covered stent was to be used in the bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.Reportedly, the lesion was not dilated prior to stent placement.According to the complainant, during the procedure, it was noted that it was ¿more difficult than usual¿ to pass the guidewire through the catheter, but eventually they were able to successfully pass it through.During deployment, the sheath was noted to have been stretched and broke at the guidewire access port.The stent failed to deploy inside the patient.The procedure was completed with another wallflex biliary rx covered stent.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 constrained wallflex biliary rx stent and delivery system was received for analysis.Visual examination of the returned device found the outer sheath was curved and broken at the proximal end of the guidewire access sheath.Functional analysis found that it was possible to manually deploy the stent.After deployment, it was noted that the distal inner shaft was slightly kinked.A 0.035 inch guidewire was inserted through the device without any tangible resistance but it was not able to properly place the guidewire given the damage to the returned device.There was no issue with the stent and no other issues were identified during the product analysis.The investigation concluded that the noted damages to the returned device 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) revealed no non-conforming events or deviations.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 to be used in the bile duct to treat a malignant stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2017.Reportedly, the lesion was not dilated prior to stent placement.According to the complainant, during the procedure, it was noted that it was ¿more difficult than usual¿ to pass the guidewire through the catheter, but eventually they were able to successfully pass it through.During deployment, the sheath was noted to have been stretched and broke at the guidewire access port.The stent failed to deploy inside the patient.The procedure was completed with another wallflex biliary rx covered stent.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: 6786423
• Report Number: 3005099803-2017-02468
• Device Sequence Number: 1491757
• Product Code: FGE
• UDI-Device Identifier: 08714729764908
• UDI-Public: (01)08714729764908(17)20190503(10)0020598890
• Combination Product (Y/N): N
• Initial Reporter State: KS
• 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): 07/24/2017

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: 05/03/2019
• Device Model Number: M00570520
• Device Catalogue Number: 7052
• Device Lot Number: 0020598890
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/26/2017
• Initial Date Received by Manufacturer: 07/24/2017
• Supplement Date Received by Manufacturer: 08/15/2017
• Initial Report FDA Received Date: 08/10/2017
• Supplement Report FDA Received Date: 09/08/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1