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

Model Number	M00547010
Medical Device Problem Codes	Break (1069); Detachment of Device or Device Component (2907); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/30/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0401 captures the reportable investigation results of catheter detached or separated.Block h11: investigation results.The returned extractor pro rx retrieval balloon was analyzed, and a visual inspection revealed a detachment of the catheter.Additionally, the catheter exhibited signs of elongation consistent with material stretching along its length.No other problems with the device were noted.The product analysis revealed a detachment of the catheter.Additionally, the catheter exhibited signs of elongation consistent with material stretching along its length.The problem observed indicates the presence of mechanical force applied to the device, which is consistent with the elongation identified along the catheter.The observed pattern is most likely associated with procedural factors such as excessive force or mechanical stress during use, which could have contributed to the reported condition.Therefore, the most probable root cause is an adverse event related to procedure.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.Review of the instructions for use (ifu) confirmed there was relevant content and sufficient guidance with respect to the circumstances described within this complaint.No updates are required to the ifu as a result of this event.A risk review was completed and confirmed that the event of catheter detached or separated was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2026.During the procedure, it was reported that the extractor balloon snapped off.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: this event has been deemed a reportable event based on the investigation results: the catheter was detached or separated.Please see block h11 for full investigation details.

• 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: 25178435
• Report Number: 3005099803-2026-01904
• Device Sequence Number: 10693318
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: (01)08714729790297(17)270922(10)37509999
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 05/14/2026

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: M00547010
• Device Catalogue Number: M00547010
• Device Lot Number: 0037509999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/17/2026
• Initial Report FDA Received Date: 05/14/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/22/2025
• 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
• Patient Sex: Unknown