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

Model Number	M00547020
Medical Device Problem Codes	Inflation Problem (1310); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/23/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a0406 captures the reportable event of balloon irregular shaped.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stone performed on (b)(6) 2025.During the preparation outside the patient, it was reported that they want to use 15-18 balloon, but the opening effect was not good during the test outside the body of patient.It was reported that the balloon could be inflated, but it won't open all the way.The procedure was completed with a different device.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: video of the complaint device outside the patient were provided by the customer and showed the balloon was inflated and shaped irregularly.
Additional Manufacturer Narrative
Block e1: the initial reporter facility name is (b)(6); reported here as the name exceeded character limit for designated field.Block h6: imdrf device code a0406 captures the reportable event of balloon irregular shaped.Block h11: investigation results the returned extractor pro rx retrieval balloon was analyzed, and a visual inspection found no problem with the device.Microscopic inspection found a tear on the balloon.Functional test was performed, and the balloon was inflated with air but inflates unevenly and was not able to hold pressure because of the tear.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon irregular shaped was confirmed.The returned balloon was found to have a tear.It is most likely to have occurred due to factors encountered during the procedure or it can be due to excess pressure.These factors and interactions could generate the problem found in the balloon.Also, it is possible that interaction with any kind of a sharp surface during or previous the procedure could create friction on the balloon, causing the tear on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat common bile duct stone performed on (b)(6) 2025.During the preparation outside the patient, it was reported that they want to use 15-18 balloon, but the opening effect was not good during the test outside the body of patient.It was reported that the balloon could be inflated, but it won't open all the way.The procedure was completed with a different device.There were no patient complications reported as a result of this event and patient's condition at the conclusion of the procedure was reported to be stable.Note: video of the complaint device outside the patient were provided by the customer and showed the balloon was inflated and shaped irregularly.

• 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: 22865613
• Report Number: 3005099803-2025-04126
• Device Sequence Number: 18047922
• Product Code: FGE
• UDI-Device Identifier: 08714729790310
• UDI-Public: (01)08714729790310(17)260717(10)34449175
• 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): 10/24/2025

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: 07/17/2026
• Device Model Number: M00547020
• Device Catalogue Number: M00547020
• Device Lot Number: 0034449175
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 09/27/2025
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 10/24/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/17/2024
• 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: 63 YR
• Patient Sex: Male
• Patient Weight: 73 KG