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

Model Number	M00547310
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/01/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, the catheter of the device broke into two separate pieces as the physician was sweeping the duct.It was reported that no piece of the device detached inside the patient.The procedure was completed with another extractor pro rx-s retrieval balloon.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block d4, h4: detailed product information was not provided to bsc.We completed a good-faith effort to obtain the information.Because the product is unknown at this time, we are unable to provide the complete unique identifier (udi) # and other product-specific information.If additional details become available, a supplemental report will be submitted.Block h2 (additional information): block b5 (describe event or problem) has been updated.Block h6: imdrf device code a0401 captures the reportable event of catheter break.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx-s retrieval balloon was attempted to be used during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat stones performed on (b)(6) 2025.During the procedure, the catheter of the device broke into two separate pieces as the physician was sweeping the duct.It was reported that no piece of the device detached inside the patient.The procedure was completed with another extractor pro rx-s retrieval balloon.No further information has been obtained despite good-faith efforts.There were no patient complications reported as a result of this event.***additional information received on july 30, 2025*** the anatomy location is the common bile duct (cbd).

• Brand Name: EXTRACTOR PRO RX-S
• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 22560069
• Report Number: 3005099803-2025-03475
• Device Sequence Number: 9637582
• Product Code: FGE
• UDI-Device Identifier: 08714729907152
• UDI-Public: (01)08714729907152
• Combination Product (Y/N): N
• Initial Reporter State: DC
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/22/2025

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 Model Number: M00547310
• Device Catalogue Number: M00547310
• 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: 07/01/2025
• Supplement Date Received by Manufacturer: 07/30/2025
• Initial Report FDA Received Date: 07/21/2025
• Supplement Report FDA Received Date: 08/22/2025
• 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