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

Model Number	M00569810
Medical Device Problem Codes	Positioning Failure (1158); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/13/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of stent punctured sheath.
Event or Problem Description
It was reported to boston scientific corporation that a wallstent rx biliary uncovered stent was used to treat an approximately 6cm malignant hilar stricture due to cholangio carcinoma during a biliary metal stenting procedure performed on november 13, 2024.The patient's anatomy was tortuous and was dilated prior to stent placement.During the procedure, it was noted that wire of the stent was coming out of the sheath, which resulted in deployment failure.The stent was removed from the patient fully covered by the outer sheath and another of the same device was used to complete the procedure.There was no patient complications reported as a result of this event.

• Brand Name: WALLSTENT RX 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: 20898990
• Report Number: 3005099803-2024-06289
• Device Sequence Number: 8949079
• Product Code: FGE
• UDI-Device Identifier: 08714729456728
• UDI-Public: 08714729456728
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030107
• 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
• Report Date (Section B): 12/10/2024

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: 09/02/2025
• Device Model Number: M00569810
• Device Catalogue Number: M00569810
• Device Lot Number: 0033547957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/13/2024
• Initial Report FDA Received Date: 12/10/2024
• Date Device Manufactured: 03/04/2024
• 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: 67 YR
• Patient Sex: Female