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

Model Number	M00558920
Medical Device Problem Codes	Inflation Problem (1310); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/24/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in an unknown anatomy location.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, balloon inflation was observed to be weak.Upon removal and subsequent table testing, leakage was detected at the distal end of the balloon.The procedure was completed with another cre rx dilatation balloon device.The type of procedure and the anatomy location of the procedure are unknown and are being reported as the balloon leak 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 a0504 captures the reportable event of a balloon leak in an unknown anatomy location.Block h11: investigation results.The returned cre rx dilatation balloon was analyzed, and a visual examination found that the balloon had no damages.Functional and microscopic inspection were performed, and the balloon was inflated without any problem; however, it was not able to hold pressure due to a pinhole in the balloon, which produces a leak.The pinhole was located approximately 42 mm from the tip.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 42 mm from the tip of the device.It is possible that the pinhole found in the balloon occurred due to factors encountered during the procedure or it can be due to excess pressure.Also, it is possible that interaction with any kind of a sharp surface during or previous to the procedure could create friction on the balloon and could have caused the pinhole found on the balloon.These factors and interactions could influence the damage found in the balloon.Therefore, the most probable root cause is adverse event related to procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used during a procedure performed on (b)(6) 2025.During the procedure, balloon inflation was observed to be weak.Upon removal and subsequent table testing, leakage was detected at the distal end of the balloon.The procedure was completed with another cre rx dilatation balloon device.The type of procedure and the anatomy location of the procedure are unknown and are being reported as the balloon leak 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: 24152569
• Report Number: 3005099803-2026-00279
• Device Sequence Number: 21319133
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: (01)08714729965473(17)280725(10)37063600
• 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,Distributor
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/24/2026

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: 0037063600
• 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: 12/26/2025
• Supplement Date Received by Manufacturer: 02/03/2026
• Initial Report FDA Received Date: 01/22/2026
• Supplement Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/26/2025
• 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