MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR¿ PRO RX-S; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547300
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/05/2026
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: patient was scheduled for an ecrp with possible stent placement.Provider was cauterizing and dilation to the ampulla.Extractor pro dilation balloon in the duct was not inflating properly.The tubing was leaking at the proximal end to the balloon.Extractor removed and replaced.No harm to patient.

• Brand Name: EXTRACTOR¿ PRO RX-S
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 100 boston scientific way; marlborough MA 01752
• MDR Report Key: 24505687
• Report Number: 24505687
• Device Sequence Number: 10509944
• Product Code: FGE
• UDI-Device Identifier: 08714729907138
• UDI-Public: (01)08714729907138
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 02/26/2026
• Report Date (Section F): 02/26/2026

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: M00547300
• Device Catalogue Number: M00547300
• Device Lot Number: 37719677
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 5 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/04/2026
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 03/04/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 43 YR
• Patient Sex: Female
• Patient Weight: 94 KG
• Date Report Sent to FDA: 02/26/2026