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

Model Number	M00547020
Medical Device Problem Code	Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a140101 captures the reportable event of balloon would not deflate.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the colon during a colonoscopy with stent placement procedure to treat colonic stricture performed on (b)(6) 2025.During the procedure, the technician prepared an extractor pro rx retrieval balloon by priming and testing it.The balloon worked when tested and then backloaded it over the guidewire and advanced it through the working channel.The physician navigated the balloon across the stricture, initially deflated, then inflated it beyond the narrowing and injected contrast to visualize the lumen under fluoroscopy.Upon attempting to deflate the balloon, the balloon did not naturally deflate when the stop cock was turned to deflate the balloon.The technician had to manually retract the pusher on the inflation device to achieve deflation.The procedure was completed with a second extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.

• Brand Name: EXTRACTOR PRO RX
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 23057944
• Report Number: 3005099803-2025-04755
• Device Sequence Number: 18447999
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: (01)08714729790310(17)261101(10)35195447
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/15/2025

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: M00547020
• Device Catalogue Number: M00547020
• Device Lot Number: 0035195447
• 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: 08/27/2025
• Initial Report FDA Received Date: 09/15/2025
• Date Device Manufactured: 11/01/2024
• 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