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

Model Number	H965430600
Medical Device Problem Codes	Positioning Failure (1158); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/31/2020
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 august 03, 2020 that a wallstent biliary uncovered stent was used to treat a malignant stenosis in the common hepatic duct during a percutaneous drainage with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy.Reportedly, it was noted that the tip of the delivery system was damaged or broken during the procedure.The procedure was completed with another wallstent 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 h6: device problem code 2978 captures the reportable event of tip damaged/defective.Block h10: a wallstent biliary uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual examination of the returned device found the outer sheath was detached from the handle and was slightly pushed out covering the tip.The outer sheath was noted to be damaged.The tip was inspected and no damages were noted.Functional evaluation revealed that it was not possible to deploy the stent using the delivery system as received; however, the stent was manually deployed by gripping the outer sheath and pulling the tip distally.The outer diameter of the stent and the stent length were measured and were found to be within specification.No other issues were noted to the stent and delivery system.The reported event of tip damaged/defective was not confirmed; the tip was inspected and no damages were noted.The reported event of stent failure to deploy was confirmed.The investigation concluded that the reported events and the observed failures were likely due to factors encountered during the procedure.It may be that how the device was handled or manipulated, the patient's tight anatomy and the use of excessive force, limited the performance of the device and contributed to the detachment of the outer sheath, the outer sheath to be pused slightly covering the tip and the stent failure to deploy.Also, it is possible that the outer sheath was damaged during the attempted deployment of the stent.Therefore, a review and analysis of all available information indicated 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.
Event or Problem Description
It was reported to boston scientific corporation on august 03, 2020 that a wallstent biliary uncovered stent was used to treat a malignant stenosis in the common hepatic duct during a percutaneous drainage with stent placement procedure performed on (b)(6) 2020.Reportedly, the patient's anatomy was tortuous and was dilated prior to stent placement.According to the complainant, during the procedure, the stent failed to deploy.Reportedly, it was noted that the tip of the delivery system was damaged or broken during the procedure.The procedure was completed with another wallstent 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.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 10444693
• Report Number: 3005099803-2020-03515
• Device Sequence Number: 2726943
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: PL
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2020

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: 09/24/2021
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0024488483
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2020
• Initial Date Received by Manufacturer: 08/03/2020
• Supplement Date Received by Manufacturer: 09/08/2020
• Initial Report FDA Received Date: 08/24/2020
• Supplement Report FDA Received Date: 09/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1