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

Model Number	M00547010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Perforation (2001); Peritonitis (2252)
Date of Event	01/01/2025
Type of Reportable Event	Death
Additional Manufacturer Narrative
Block b2: approximated based on the reported patient death date of (b)(6) 2025.Block b3: approximated based on the reported event date of january 2025.Block d4, h4: the complainant was unable to provide the lot number.Therefore, the manufacture and expiration dates are unknown.Block h6: imdrf patient code e2114 is being used to capture the reportable event of perforation.Imdrf patient code e1024 is being used to capture the reportable event of peritonitis.Imdrf impact code f02 is being used to capture the reportable event of patient death.
Event or Problem Description
It was reported to boston scientific corporation that an extractor pro rx retrieval balloon was used in the bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure performed in (b)(6) 2025.The exact procedure date was not reported.During the procedure, a perforation occurred near the duodenum.It was reported that the physician suspects that the extractor pro rx retrieval balloon may be a contributing factor in causing the perforation.The procedure was completed using the same original device.The patient passed away in (b)(6) 2025 due to peritonitis.The exact patient death date was not reported.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21978283
• Report Number: 3005099803-2025-01885
• Device Sequence Number: 7264946
• Product Code: FGE
• UDI-Device Identifier: 08714729790297
• UDI-Public: (01)08714729790297
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• 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): 05/07/2025

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00547010
• Device Catalogue Number: M00547010
• 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: 04/10/2025
• Initial Report FDA Received Date: 05/07/2025
• 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: Other; Death
• Patient Sex: Unknown