MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION EXTRACTOR PRO XL; CATHETER, BILIARY, DIAGNOSTIC

Model Number	M00547140
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/02/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Imdrf impact code f2301 captures the reportable event of additional device required.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro xl retrieval balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed to treat stones on (b)(6) 2026.During the procedure, the device could not be removed from the bile duct because it could no longer be deflated.Extensive manipulation with multiple suction syringes, including cutting the balloon port, was unsuccessful.Intubation was performed using an ercp catheter and advanced to the point where the balloon became blocked.Various wires were then advanced, but these did not cause the balloon to burst.A needle knife was then attempted, including short electrical current pulses.This also proved unsuccessful.As a last resort, a jagwire was used, and a regular-size scivita cholangioscope was advanced.Advancement to the impacted balloon catheter revealed a stone-like pattern in the ductus hepaticus (dhs).Individual stones were visualized using electrocautery until the balloon was seen.A single electrocautery pulse was then applied to the balloon, causing it to burst.The balloon catheter was then removed orally without difficulty.Finally, an 8.5f/15cm flexima stent (neps) was inserted to complete the procedure.Due to this event, the procedure extended the examination time, however, the amount of additional procedure time could not be obtained and was reported to be unavailable by the customer/account.There were no patient complications reported as a result of this event.

• Brand Name: EXTRACTOR PRO XL
• Common Device Name: CATHETER, BILIARY, DIAGNOSTIC
• Manufacturer (Section D): BOSTON SCIENTIFIC CORPORATION; 300 boston scientific way; marlborough MA 01752
• Manufacturer (Section G): BOSTON SCIENTIFIC CORK LIMITED; cork business technology park; model farm road; cork T12 Y K88; EI T12 YK88
• Manufacturer Contact: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 24264149
• Report Number: 3005099803-2026-00462
• Device Sequence Number: 13248824
• Product Code: FGE
• UDI-Device Identifier: 08714729790365
• UDI-Public: (01)08714729790365(17)270611(10)36732928
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K102082
• 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
• Report Date (Section B): 02/04/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: M00547140
• Device Catalogue Number: M00547140
• Device Lot Number: 0036732928
• 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: 01/12/2026
• Initial Report FDA Received Date: 02/04/2026
• Date Device Manufactured: 06/11/2025
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female