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

Model Number	M00547000
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Erosion (1750); Hemorrhage/Blood Loss/Bleeding (1888); Hypovolemic Shock (1917); Reduced Blood Flow (4598)
Date of Event	03/12/2026
Type of Reportable Event	Death
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 patient code e0506 captures the reportable event of hemorrhage/bleeding.Imdrf patient code e0519 captures the reportable event of reduced blood flow.Imdrf patient code e233603 captures the reportable event of hypovolemic shock.Imdrf patient code e2006 captures the reportable event of erosion.Imdrf impact code f02 captures the reportable event of death.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required.
Event or Problem Description
Note: this report pertains to an extractor pro retrieval balloon and wallflex biliary stents used in the same patient and procedure.It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat metastatic pancreatic cancer and common bile duct obstruction performed on (b)(6) 2026.Post procedure, 6 months after stent implantation, a partially covered metal biliary stent was reported to have been occluded.During an ercp performed for an occluded pancreatic cancer related biliary metal stent, an extractor balloon was used to sweep obstructing sludge from the duct, and it was suspected that simply sweeping the duct led to a dislodging of a clot, which resulted in bleeding.Spyglass visualization revealed a pulsatile bleeding site located a cm or two above the proximal end of the stent concerning for vascular erosion.Multiple hemostatic measures were attempted, including use of a hurricane balloon, epinephrine injection, and placement of a fully covered metal stent.Despite these efforts, the patient became hemodynamically unstable, required blood transfusion, and an emergent interventional radiology procedure was planned.The physician did not believe that the extractor balloon malfunctioned or directly caused any harm or injury.The patient died before the interventional radiology (ir) team could intervene.It was reported that the patient had significant comorbidities including metastatic cancer involving multiple sites, including the liver and cbd that may have contributed to the patient's death.
Event or Problem Description
Note: this report pertains to an extractor pro retrieval balloon and wallflex biliary stents used in the same patient and procedure.It was reported to boston scientific corporation that an extractor pro retrieval balloon was used in the common bile duct during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat metastatic pancreatic cancer and common bile duct obstruction performed on (b)(6) 2026.Post procedure, 6 months after stent implantation, a partially covered metal biliary stent was reported to have been occluded.During an ercp performed for an occluded pancreatic cancer related biliary metal stent, an extractor balloon was used to sweep obstructing sludge from the duct, and it was suspected that simply sweeping the duct led to a dislodging of a clot, which resulted in bleeding.Spyglass visualization revealed a pulsatile bleeding site located a cm or two above the proximal end of the stent concerning for vascular erosion.Multiple hemostatic measures were attempted, including use of a hurricane balloon, epinephrine injection, and placement of a fully covered metal stent.Despite these efforts, the patient became hemodynamically unstable, required blood transfusion, and an emergent interventional radiology procedure was planned.The physician did not believe that the extractor balloon malfunctioned or directly caused any harm or injury.The patient died before the interventional radiology (ir) team could intervene.It was reported that the patient had significant comorbidities including metastatic cancer involving multiple sites, including the liver and cbd that may have contributed to the patient's death.
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 (correction): block h6 (patient codes) have been corrected.Block h6: imdrf patient code e0506 captures the reportable event of hemorrhage/bleeding.Imdrf patient code e233603 captures the reportable event of hypovolemic shock.Imdrf impact code f02 captures the reportable event of death.Imdrf impact code f2302 captures the reportable event of blood transfusion.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f23 captures the reportable event of unexpected medical intervention.Imdrf impact code f2303 captures the reportable event of medication required.Block h11: investigation results: the device was not returned for analysis and was reported to be disposed; therefore, a technical analysis could not be performed.There is no evidence to suggest a malfunction or performance problem with the extractor pro retrieval balloon.The reporting physician indicated that the device did not directly cause or contribute to the injury.With all available information, boston scientific concludes the reported events including blood transfusion, additional device required, unexpected medical intervention, medication required, shock and hypovolemic are most appropriately classified as adverse event related to procedure.These events are consistent with known procedural risks associated with biliary intervention, particularly in the context of ductal sweeping and management of an occluded biliary stent.Additionally, the reported event of death is most appropriately classified as an adverse event related to the patient condition, given the patient's advanced metastatic pancreatic cancer involving multiple sites, including the liver and common bile duct, which significantly increased the risk of severe complications.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of adverse event related to the patient condition.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.However, a ship history review was performed to identify the most probable lot numbers, and a manufacturing review of the most probable lot numbers did not identify any anomalies or deviations that could have contributed to the event.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.

• 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: 24809037
• Report Number: 3005099803-2026-01250
• Device Sequence Number: 18812025
• Product Code: FGE
• UDI-Device Identifier: 08714729790266
• UDI-Public: (01)08714729790266
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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): 05/26/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: M00547000
• Device Catalogue Number: M00547000
• 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: 03/12/2026
• Supplement Date Received by Manufacturer: 04/27/2026
• Initial Report FDA Received Date: 04/07/2026
• Supplement Report FDA Received Date: 05/26/2026
• 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
• Outcome Attributed to Adverse Event: Death; Other; Required Intervention
• Patient Sex: Unknown