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 Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).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 tip was damaged.Functional inspection found the stent could fully deploy without any resistance.No other issues were noted to the stent and delivery system.The reported event of stent failure to deploy could not be confirmed as the stent was able to deploy without resistance during functional inspection.The investigation concluded that the observed failure of tip damaged was likely due to procedural factors encountered during the procedure.It may be that handling and manipulation of the device during procedure could lead to the tip damage.However, because the reported event could not be confirmed, a review and analysis of all available information indicated the most probable cause is no problem detected.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 bliary uncovered stent was implanted in the common bile duct to treat jaundice during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2021.Reportedly, the patient's anatomy was not dilated prior to stent placement.During the procedure, the stent could not be deployed.The stent was fully covered by the outer sheath when it was removed from the patient.The procedure was completed with another wallstent bliary 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.Note: this event has been deemed an mdr reportable event based on investigation result which revealed the tip was damaged.

• Brand Name: WALLSTENT BILIARY
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carol morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 13483458
• Report Number: 3005099803-2022-00556
• Device Sequence Number: 5437772
• Product Code: FGE
• UDI-Device Identifier: 08714729204688
• UDI-Public: 08714729204688
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/08/2022

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: 07/20/2023
• Device Model Number: H965430600
• Device Catalogue Number: 3060
• Device Lot Number: 0027698966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/17/2022
• Initial Report FDA Received Date: 02/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/20/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Weight: 72 KG