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

Model Number	H965431200
Medical Device Problem Code	Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary partially covered stent was to be implanted in the common bile duct to treat a stenosis secondary to pancreatic neoplasm during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on october 19, 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, an attempt to place the stent in the common bile duct was performed; however, when the device was maneuvered, the stent was released before reaching the target location.The stent was removed using snare and another wallstent biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition after the procedure was reported to be stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a1502 captures the reportable event of stent positioning issue.A wallstent biliary partially covered stent and delivery system were received for analysis.The stent was received fully deployed and expanded.Visual inspection was performed and no problems were noted with the stent and delivery system.The reported event of stent positioning issue was not confirmed because this happened during the procedure and is not possible to replicate in the laboratory of analysis.In addition, the stent was received fully deployed and expanded.The device met all the manufacturing specifications, passed all control and visual inspections, and no problems were reported during the assembly process.Therefore, a review and analysis of all available information indicated the most probable cause is no problem detected.A product labeling review identified that the device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent biliary partially covered stent was to be implanted in the common bile duct to treat a stenosis secondary to pancreatic neoplasm during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on (b)(6) 2023.The patient's anatomy was tortuous and was not dilated prior to stent placement.During the procedure, an attempt to place the stent in the common bile duct was performed; however, when the device was maneuvered, the stent was released before reaching the target location.The stent was removed using snare and another wallstent biliary stent was used to complete the procedure.There were no patient complications reported as a result of this event and the patient's condition after 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
• Manufacturer (Section G): BOSTON SCIENTIFIC CORPORATION; ballybrit business park; galway ; EI
• Manufacturer Contact: carole morley ; 300 boston scientific way; marlborough, MA 01752 ; 5086834015
• MDR Report Key: 18233638
• Report Number: 3005099803-2023-06312
• Device Sequence Number: 6937041
• Product Code: FGE
• UDI-Device Identifier: 08714729229902
• UDI-Public: 08714729229902
• Combination Product (Y/N): N
• Initial Reporter Country: UY
• PMA/510(K) Number: K000308
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 03/20/2024
• Device Model Number: H965431200
• Device Catalogue Number: 43120
• Device Lot Number: 0029081295
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/03/2023
• Supplement Date Received by Manufacturer: 12/07/2023
• Initial Report FDA Received Date: 11/29/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2022
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male