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

Model Number	M00574650
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/21/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the stent externalized following deployment.The target lesion was located in the mildly tortuous and mildly calcified vessel.An 8mmx100mm wallflex biliary transhepatic was advanced for treatment.During the procedure, the stent externalized following deployment.It came out when the delivery system was being removed.The procedure was completed using an alternative method.No complications were reported.
Additional Manufacturer Narrative
Device evaluated by mfr.: the stent was returned fully expanded and deployed.Additionally, the outer sheath was returned kinked.Based on the analysis of the returned product, the reported allegation of stent migration could not be confirmed, because it happened during the procedure.
Event or Problem Description
It was reported that the stent externalized following deployment.The target lesion was located in the mildly tortuous and mildly calcified vessel.An 8mmx100mm wallflex biliary transhepatic was advanced for treatment.During the procedure, the stent externalized following deployment.It came out when the delivery system was being removed.The procedure was completed using an alternative method.No complications were reported.

• Brand Name: WALLFLEX BILIARY TRANSHEPATIC
• 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: rachel shields ; 4100 hamline ave n; arden hills, MN 55112 ; 6512422111
• MDR Report Key: 20707130
• Report Number: 2124215-2024-71613
• Device Sequence Number: 20845966
• Product Code: FGE
• UDI-Device Identifier: 08714729799436
• UDI-Public: 08714729799436
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K112543
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/31/2025

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: 11/25/2025
• Device Model Number: M00574650
• Device Catalogue Number: M00574650
• Device Lot Number: 0032925631
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 11/18/2024
• Supplement Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/26/2023
• 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 Sex: Unknown