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

Model Number	M00547000
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Material Twisted/Bent (2981)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	05/28/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0501 captures the reportable event of balloon tip detachment.Imdrf device code a040609 captures the reportable event of balloon tip bent.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloons was attempted to be used in the duodenum during an endoscopic retrograde cholangiopancreatography (ercp) procedure for stone removal in common bile duct performed on (b)(6) 2026.During the procedure, after the duct was swept and debris was removed.Upon withdrawal of the balloon catheter, the distal tip of the catheter detached and was left in the duodenum.The balloon itself remained intact and did not separate into the patient.The physician was not using a guidewire during the procedure, and it appears the catheter tip bent and subsequently broke.The procedure was completed with same device.There were no patient complications reported as a result of this event.The patients condition at the conclusion of the procedure was reported to be fully recovered.

• 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: 25553583
• Report Number: 3005099803-2026-02525
• Device Sequence Number: 10762926
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: (01)08714729790266(17)280322(10)38904752
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 07/14/2026

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: M00547000
• Device Catalogue Number: M00547000
• Device Lot Number: 0038904752
• 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: 05/28/2026
• Supplement Date Received by Manufacturer: 06/19/2026
• Initial Report FDA Received Date: 06/18/2026
• Supplement Report FDA Received Date: 07/14/2026
• Date Device Manufactured: 03/23/2026
• 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