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

Model Number	M00569650
Medical Device Problem Codes	Difficult to Remove (1528); Positioning Problem (3009)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The patients exact age was not reported, however the patient was reported to be over the age of 18.The health care facility address 1 is (b)(6).(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 march 20, 2020 that a wallstent biliary rx uncovered stent was to be used to treat a 1.5 cm malignant stricture in the lower common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, during catheter removal, the delivery system got stucked on the stent.The physician exerted force to remove the delivery system and the stent was displaced.The stent was removed with a snare and the procedure was completed with another wallstent 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 a2: the patients exact age was not reported, however the patient was reported to be over the age of 18.Block e1: the health care facility address 1 is (b)(6) block h6: device problem code 3009 captures the reportable event of stent positioning issue.Device problem code 1528 captures the reportable event of delivery system difficult to remove.Block h10: investigation results a wallstent biliary rx delivery system was received for analysis; the stent was not returned.Visual examination of the returned device found that the outer blue sheath was kinked approximately at 43 cm from the tip of the delivery system.No other issues were noted.Taking all available information into consideration, the investigation concluded that the reported events and the observed failure are most likely due to factors encountered during the procedure such as how the device was handled and/ or manipulated, the interaction with the scope, the patient anatomy and the use of an excessive force during withdrawal attempts of the delivery system, 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 the 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 (b)(6), 2020 that a wallstent biliary rx uncovered stent was to be used to treat a 1.5 cm malignant stricture in the lower common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6), 2020.According to the complainant, during the procedure, the stent was able to be deployed; however, during catheter removal, the delivery system got stucked on the stent.The physician exerted force to remove the delivery system and the stent was displaced.The stent was removed with a snare and the procedure was completed with another wallstent 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.

• Brand Name: WALLSTENT RX BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• MDR Report Key: 9945818
• Report Number: 3005099803-2020-01553
• Device Sequence Number: 19024213
• Product Code: FGE
• UDI-Device Identifier: 08714729296850
• UDI-Public: 08714729296850
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K012752
• 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): 05/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 01/12/2021
• Device Model Number: M00569650
• Device Catalogue Number: 6965
• Device Lot Number: 0024106381
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2020
• Initial Date Received by Manufacturer: 03/20/2020
• Supplement Date Received by Manufacturer: 04/23/2020
• Initial Report FDA Received Date: 04/09/2020
• Supplement Report FDA Received Date: 05/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention