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

Model Number	M00547020
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Failure to Deflate (4060)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat jaundice performed on (b)(6) 2025.During the procedure, the balloon had a slow deflation process when the stone removal balloon was removed for the second time, and it was the same when it was withdrawn and tested outside of the patient.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.
Additional Manufacturer Narrative
Block e1: initial reporter's facility name is (b)(6); reported here as the facility name exceeded the character limit for the designated field.Block h6: imdrf device code a140101 captures the reportable event of balloon failure to deflate.Block h11: investigation results the returned extractor pro rx retrieval balloon was analyzed, and a visual inspection found that the catheter was kinked.After a functional and microscope inspection, the device was inflated with air, and the balloon was able to be inflated and deflated without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon failure to deflate was not confirmed.The results of the analysis performed on the returned device found that the balloon was in good conditions and with the capability of being inflated and hold its pressure without any evidence of an air leak, and it was further confirmed that the balloon could be inflated and deflated without any problem.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was attempted to be used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat jaundice performed on (b)(6) 2025.During the procedure, the balloon had a slow deflation process when the stone removal balloon was removed for the second time, and it was the same when it was withdrawn and tested outside of the patient.The procedure was completed with another extractor pro rx retrieval balloon.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be stable.

• 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: christina lam ; 300 boston scientific way; marlborough, MA 01752 ; 9145716918
• MDR Report Key: 23287455
• Report Number: 3005099803-2025-05207
• Device Sequence Number: 14842834
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: (01)08714729790310(17)260625(10)34308277
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/17/2025

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: 06/25/2026
• Device Model Number: M00547020
• Device Catalogue Number: M00547020
• Device Lot Number: 0034308277
• 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: 09/17/2025
• Supplement Date Received by Manufacturer: 11/22/2025
• Initial Report FDA Received Date: 10/15/2025
• Supplement Report FDA Received Date: 12/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/25/2024
• 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: 67 YR
• Patient Sex: Male
• Patient Weight: 56 KG