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

Model Number	M00570530
Medical Device Problem Code	Unsealed Device Packaging (1444)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h11: imdrf device code a020503 captures the reportable event of packaging seal compromised.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, while opening the package, there was an air leakage, and it could no longer be used.Additional information was received stating that the air leakage was found in the device packaging and from the seal.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.
Additional Manufacturer Narrative
Block e1: initial reporter's address and city have been corrected.Block h6: imdrf device code a020503 captures the reportable event of packaging seal compromised.Block h11: a wallflex biliary fully covered stent was returned for analysis without its packaging.The stent was received in an undeployed state.Visual examination confirmed that the device showed no signs of damage.Product analysis could not confirm the reported event of a compromised packaging seal, as the packaging was not returned.Consequently, the investigation findings do not provide a definitive conclusion regarding the cause of the reported event.Therefore, a review and analysis of all available information indicated the most probable cause is cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary stent was implanted in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed on (b)(6) 2025.During the preparation, while opening the package, there was an air leakage, and it could no longer be used.Additional information was received stating that the air leakage was found in the device packaging and from the seal.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.

• Brand Name: WALLFLEX 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21273487
• Report Number: 3005099803-2025-00250
• Device Sequence Number: 17096336
• Product Code: FGE
• UDI-Device Identifier: 08714729764915
• UDI-Public: 08714729764915
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K140630
• 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): 03/24/2025

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: 01/09/2026
• Device Model Number: M00570530
• Device Catalogue Number: M00570530
• Device Lot Number: 0033182344
• 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: 01/02/2025
• Supplement Date Received by Manufacturer: 02/26/2025
• Initial Report FDA Received Date: 01/30/2025
• Supplement Report FDA Received Date: 03/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2024
• 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: 72 YR
• Patient Sex: Male
• Patient Weight: 81 KG