MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION WALLFLEX BILIARY; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00570530
Medical Device Problem Code	Premature Activation (1484)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter city: (b)(6).(b)(4).The device has been received for analysis; however, the analysis has not yet been completed.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 that a wallflex biliary stent was to be implanted to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography(erco) procedure performed on (b)(6) 2020.According to the complainant, during the procedure, after advancing to the biopsy channel, the stent fully deployed prematurely inside the scope.The procedure was completed with another wallflex biliary 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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was to be implanted to treat a malignant stricture in the common bile duct during an endoscopic retrograde cholangiopancreatography(ercp) procedure performed on (b)(4) 2020.According to the complainant, during the procedure, after advancing to the biopsy channel, the stent fully deployed prematurely inside the scope.The procedure was completed with another wallflex biliary 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 stable.
Additional Manufacturer Narrative
Block e1: initial reporter city: (b)(6).Block h6: problem code 1484 captures the reportable event of stent prematurely deployed.Block h10: a wallflex biliary rx stent delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found the outer blue sheath was kinked approximately at 45 cm from the tip of the delivery system.No other issues were noted to the device.The reported event of premature deployment was not confirmed because this event occurred during procedure and it is not possible to replicate these events in the laboratory.Taking all available information into consideration, the investigation concluded that the reported event and the observed failure may likely be due to some factors encountered during the procedure such as how the device was handled or manipulated, the techniques used by the user, the interaction of the device with the scope, the anatomy of the patient and the amount of force applied during the attempted deployment, which limited the performance of the device.Therefore, the most probable cause is adverse event related to procedure.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 labeling review was performed, and from the information available, this device was used per the directions for use (dfu) / product label.

• Brand Name: WALLFLEX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10043059
• Report Number: 3005099803-2020-01820
• Device Sequence Number: 3081848
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/08/2020

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: 09/02/2021
• Device Model Number: M00570530
• Device Catalogue Number: 7053
• Device Lot Number: 0024367215
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2020
• Initial Date Received by Manufacturer: 04/14/2020
• Supplement Date Received by Manufacturer: 05/14/2020
• Initial Report FDA Received Date: 05/11/2020
• Supplement Report FDA Received Date: 06/08/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 55