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

Model Number	M00570640
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/01/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be used in the duodenum, common bile duct and papilla to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During unpacking, the stent was noted to be broken and fractured.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 h6: imdrf device code a0401 captures the reportable event of stent break.
Additional Manufacturer Narrative
Block b3: approximated based on the date the manufacturer became aware of the event.Block b5 has been updated with the additional information received on february 19, 2025.Block e1 (initial reporter facility name and zip code/postal code) have been corrected.Block h6: imdrf device code a0401 captures the reportable event of stent break.
Event or Problem Description
It was reported to boston scientific corporation that a wallflex biliary rx uncovered stent was to be used in the duodenum, common bile duct and papilla to treat a stricture during an endoscopic retrograde cholangiopancreatography (ercp) with stent placement procedure performed on an unknown date.During unpacking, the stent was noted to be broken and fractured.The procedure was completed with another of the same device.There was no patient complication reported as a result of this event.Additional information received on february 19, 2025.It was reported that the device was unpacked and then inserted inside the patient.The physician then noticed that the stent was broken.

• 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: 21360234
• Report Number: 3005099803-2025-00499
• Device Sequence Number: 8481701
• Product Code: FGE
• UDI-Device Identifier: 08714729756231
• UDI-Public: 08714729756231
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/13/2025

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 Model Number: M00570640
• Device Catalogue Number: M00570640
• Device Lot Number: 0035129648
• 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: 01/28/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/11/2025
• Supplement Report FDA Received Date: 03/13/2025
• Date Device Manufactured: 10/23/2024
• 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 Sex: Unknown