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

Model Number	M00547000
Medical Device Problem Codes	Difficult to Remove (1528); Use of Device Problem (1670); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	11/14/2025
Type of Reportable Event	Serious Injury
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones and indeterminate stricture performed on (b)(6) 2025.During the procedure, after several passes and retrieval attempts, the balloon catheter could not be removed from the duct, likely lodged between the stone, stricture, and duct wall.Despite applying significant traction, the catheter could not be removed.The catheter was cut outside the scope to withdraw the scope, then reintroduced the scope and trimmed the catheter within the duodenum, leaving only a minimal portion protruding from the common bile duct.After the final cut, the distal tip dislodged and floated above the stricture.Attempts to retrieve the tip using stricture dilation via spyglass ds, and spybite max were unsuccessful because the common bile duct was too dilated and the tip was floating around too much.Consequently, a 10x60 wallflex fully covered stent was placed to open up the stricture and possibly have the tip of the catheter fall through the stent and out of the duct.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 have fully recovered and that the patient will return in a few weeks to determine if the catheter tip has fallen out though the stent.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon catheter tip detached.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f2301 captures the reportable event of additional devices required.
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 common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones and indeterminate stricture performed on (b)(6) 2025.During the procedure, after several passes and retrieval attempts, the balloon catheter could not be removed from the duct, likely lodged between the stone, stricture, and duct wall.Despite applying significant traction, the catheter could not be removed.The catheter was cut outside the scope to withdraw the scope, then reintroduced the scope and trimmed the catheter within the duodenum, leaving only a minimal portion protruding from the common bile duct.After the final cut, the distal tip dislodged and floated above the stricture.Attempts to retrieve the tip using stricture dilation via spyglass ds, and spybite max were unsuccessful because the common bile duct was too dilated and the tip was floating around too much.Consequently, a 10x60 wallflex fully covered stent was placed to open up the stricture and possibly have the tip of the catheter fall through the stent and out of the duct.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 have fully recovered and that the patient will return in a few weeks to determine if the catheter tip has fallen out though the stent.
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon catheter tip detached.Imdrf patient code e2008 captures the reportable event of unretrieved device fragment.Imdrf impact code f2301 captures the reportable event of additional devices required.Block h11: investigation results: the extractor pro rx retrieval balloon device was not returned as it was reported to be disposed.A technical analysis could not be performed.However, a media analysis was performed on the photos provided by the complainant where it can be observed x-ray images and the pouch with product information.No other problems with the device were noted.According to the media analysis performed, it was inconclusive to determine the reported events based on the x-ray images, for this reason and due to the lack of evidence it is unable to confirm the reported event of tip detachment of device or device component.However, based on the evidence provided, it was reported that the catheter was cut outside the scope, according to the information provided the device was cut in such a way that it could be out of scope, which represents a clear alteration of the device.The investigation concluded that, without analysis of the device, the most probable root cause of the clinical observations is cause not established.

• 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: 23752441
• Report Number: 3005099803-2025-06587
• Device Sequence Number: 9428862
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: (01)08714729790266(17)270724(10)37051237
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,Followup
• Report Date (Section B): 01/20/2026

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: M00547000
• Device Catalogue Number: M00547000
• Device Lot Number: 0037051237
• 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: 11/14/2025
• Supplement Date Received by Manufacturer: 12/30/2025
• Initial Report FDA Received Date: 12/08/2025
• Supplement Report FDA Received Date: 01/20/2026
• Date Device Manufactured: 07/24/2025
• 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: Unknown