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

Model Number	M00558920
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used during a procedure performed on (b)(6) 2025.During the procedure, the balloon had a hole, and water leaked out when pressure was applied.Since it was used at 8 mm and the leak was minimal, it was continuously used as it is.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.The type of procedure and the anatomy location of the procedure are unknown and are being reported as the pinhole may have occurred in the esophagus.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in an unknown anatomy location.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the reportable event of a balloon pinhole in an unknown anatomy location.Block h11: investigation results the returned cre rx biliary dilatation balloon was analyzed, and a visual inspection found no damages to the device.Functional inspection was performed, and the balloon was able to be inflated without any problem; however, it was not able to hold the pressure due to it had a pinhole in the balloon, located approximately at 43 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon pinhole was confirmed.The pinhole found is likely to have occurred due to procedural factors such as excess of pressure, interaction with other devices, or anatomical conditions.Also, it is possible that interaction with a sharp surface during or previous to the procedure, could have caused the problem found on the distal section of the balloon.Therefore, the most probable root cause is an adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx biliary dilatation balloon was used during a procedure performed on (b)(6) 2025.During the procedure, the balloon had a hole, and water leaked out when pressure was applied.Since it was used at 8 mm and the leak was minimal, it was continuously used as it is.The procedure was completed with the original device.No further information has been obtained despite good faith efforts.The type of procedure and the anatomy location of the procedure are unknown and are being reported as the pinhole may have occurred in the esophagus.There were no patient complications reported as a result of this event.

• 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: 23442412
• Report Number: 3005099803-2025-05725
• Device Sequence Number: 8626110
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: (01)08714729965473(17)271007(10)35007259
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172520
• 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,Followup
• Report Date (Section B): 12/22/2025

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: M00558920
• Device Catalogue Number: M00558920
• Device Lot Number: 0035007259
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Supplement Date Received by Manufacturer: 11/27/2025
• Initial Report FDA Received Date: 10/31/2025
• Supplement Report FDA Received Date: 12/22/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/07/2024
• 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