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

Model Number	M00558920
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Pancreatitis (4481)
Date of Event	12/19/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the bile duct during a cholangoioscopy procedure to treat jaundice performed on (b)(6) 2025.During the procedure, two scivita scopes were used; however, neither provided an image or signal on the monitor.A larger scivita scope was then used, but it was too large to access the bile duct.As a result, the physician performed a balloon sphincteroplasty, which led to major hemorrhage.The bleeding was managed with an adrenaline injection and placement of a fully covered metal stent.It was also reported that the patient developed pancreatitis.Due to these events, the procedure was not completed.The patient was reported to have recovered after embolization.
Additional Manufacturer Narrative
Block d4, h4: it was reported that upn m00558920, lot 34636266 and lot 34526682, were involved, with one device used and one device opened in error.However, the specific lot number that was used during the procedure could not be confirmed and was unavailable per account.Therefore, upn (m00558920) was used to process the complaint.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 e1021 captures the reportable event of pancreatitis.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.
Additional Manufacturer Narrative
It was reported that upn m00558920, lot 34636266 and lot 34526682, were involved, with one device used and one device opened in error.However, the specific lot number that was used during the procedure could not be confirmed and was unavailable per account.Therefore, upn (m00558920) was used to process the complaint.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 patient code e0506 captures the reportable event of hemorrhage/bleeding.Imdrf patient code e1021 captures the reportable event of pancreatitis.Imdrf impact code f2301 captures the reportable event of additional device required.Imdrf impact code f2303 captures the reportable event of medication required.Imdrf impact code f1001 captures the reportable event of aborted/cancelled procedure.Block h11: investigation results the device was not returned for analysis and was reported not available for return; therefore, a technical analysis could not be performed.A review of the manufacturing documentation for this device was unable to be performed as the lot number is unknown.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.A risk review was completed and confirmed that the events of hemorrhage, major, pancreatitis, additional device required, medication required and cancelled/rescheduled - post sedation/sedation unknown was defined in the risk documentation.This event type has been accounted for during product risk analysis to support acceptable risk benefit for the product.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of cause not established.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was used in the bile duct during a cholangoioscopy procedure to treat jaundice performed on (b)(6) 2025.During the procedure, two scivita scopes were used; however, neither provided an image or signal on the monitor.A larger scivita scope was then used, but it was too large to access the bile duct.As a result, the physician performed a balloon sphincteroplasty, which led to major hemorrhage.The bleeding was managed with an adrenaline injection and placement of a fully covered metal stent.It was also reported that the patient developed pancreatitis.Due to these events, the procedure was not completed.The patient was reported to have recovered after embolization.Additional information received on april 7, 2026.It was reported that the procedure was aborted after the patient had a significant bleed.The procedure was being rescheduled once the patient recovered from the bleed; however, the rescheduled procedure date remains unknown despite good faith efforts.

• Brand Name: CRE 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: 24748832
• Report Number: 3005099803-2026-01171
• Device Sequence Number: 8672849
• Product Code: FGE
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K172520
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 05/06/2026

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: M00558920
• Device Catalogue Number: M00558920
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 04/07/2026
• Initial Report FDA Received Date: 03/31/2026
• Supplement Report FDA Received Date: 05/06/2026
• 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: Required Intervention
• Patient Sex: Unknown