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

Model Number	M00570890
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/29/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).The device has not been received for analysis; therefore a failure analysis of the complaint device could not be completed.If any further relevant information is identified, 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 uncovered stent was to be used to treat a 2 cm malignant stricture caused by pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician tried to deploy the stent but the outer sheath broke close to the guidewire access port.The stent was removed from the patient fully constrained and the procedure was completed with a different device.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 constrained wallflex biliary rx uncovered stent was received for analysis.Visual examination of the returned device found the clear outer sheath was curved.The outer sheath was kinked, and was broken at the proximal end of the guidewire access port.Functional evaluation found it was possible to manually deploy the stent.After deployment, it was noted that the distal inner shaft was kinked.There were no issues noted with the stent and no other issues were noted during the product analysis.The noted damages to the device was likely due to anatomical or procedural factors, such as tight anatomy, encountered during the procedure, which limited the performance of the device.Therefore, the most probable root cause of the complaint 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 uncovered stent was to be used to treat a 2 cm malignant stricture caused by pancreatic cancer during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2017.Reportedly, the patient's anatomy was tortuous and was not dilated prior to stent placement.According to the complainant, during the procedure, the physician tried to deploy the stent but the outer sheath broke close to the guidewire access port.The stent was removed from the patient fully constrained and the procedure was completed with a different device.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: 6810681
• Report Number: 3005099803-2017-02423
• Device Sequence Number: 16386164
• Product Code: FGE
• UDI-Device Identifier: 08714729765332
• UDI-Public: (01)08714729765332(17)20180921(10)0019744820
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 07/31/2017

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: 09/21/2018
• Device Model Number: M00570890
• Device Catalogue Number: 7089
• Device Lot Number: 0019744820
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2017
• Initial Date Received by Manufacturer: 07/31/2017
• Supplement Date Received by Manufacturer: 09/20/2017
• Initial Report FDA Received Date: 08/22/2017
• Supplement Report FDA Received Date: 10/12/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 61 YR