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

Model Number	H965430600
Medical Device Problem Codes	Break (1069); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The patient's exact age was not reported, however, the patient was reported to be over the age of 18.(b)(6).(b)(4) captures the reportable investigation findings of stent wire punctured.A wallstent biliary uncovered stent and delivery system were received for analysis.The stent was received fully covered and undeployed.Visual inspection was performed and it was found that the valve body assembly was detached from the shaft.The outer clear sheath was kinked at the distal section.The wires of the stent punctured the outer clear sheath.No other issues were noted to the stent and delivery system.The reported event of handle broken was confirmed.Drag marks observed in the shaft indicate that the components (valve body assembly and shaft) were joined prior separation.The investigation concluded that the procedural or anatomical factors encountered during the procedure limited the performance of the device, contributing to the reported and observed failures of the device.It is likely that the kink in the outer clear sheath at the distal section was either due to the interaction with the scope when the device was advanced or hitting the device against a hard surface.Once the outer clear sheath was kinked, resistance would have occurred and the force applied to the handle when the stent was attempted to be deployed could have caused the punctured outer sheath and handle break.Therefore, a review and analysis of all available information indicated the most probable cause is adverse event related to procedure.A review of the manufacturing documentation for this device revealed that no anomalies or deviations related to the event occurred during manufacturing.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary uncovered stent was to be implanted to treat a 4cm malignant stricture in the middle of the common bile duct during a stent placement procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not tortuous and was dilated prior to stent placement.During the procedure, the handle got detached from the catheter.The procedure was completed with another wallstent biliary stent.There were no patient complications as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.Note: this event has been deemed an mdr reportable event based on the investigation results which revealed that the stent wire punctured the clear outer sheath.

• 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: 12159417
• Report Number: 3005099803-2021-03475
• Device Sequence Number: 4723475
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K982184
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/13/2021

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: 07/14/2021
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0024108968
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2021
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/23/2021
• Initial Report FDA Received Date: 07/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1