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

Model Number	M00558650
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/14/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.
Event or Problem Description
Note: this report pertains to one of three devices that were used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2025.During the procedure, they inflated the balloon, and water was leaking out.The balloon was removed from the patient, and a balloon leak was observed.Two additional cre pro wireguided dilatation balloons were attempted to be used but also leaked during use.The procedure was completed with a fourth cre pro wireguided dilatation balloon.The anatomy location during the leak is unknown and is being reported as it may have occurred in the esophagus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Event or Problem Description
Note: this report pertains to one of three devices that were used in the same patient and procedure.It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during an esophagogastroduodenoscopy (egd) procedure to treat stricture performed on (b)(6) 2025.During the procedure, they inflated the balloon, and water was leaking out.The balloon was removed from the patient, and a balloon leak was observed.Two additional cre pro wireguided dilatation balloons were attempted to be used but also leaked during use.The procedure was completed with a fourth cre pro wireguided dilatation balloon.The anatomy location during the leak is unknown and is being reported as it may have occurred in the esophagus.There were no patient complications reported as a result of this event.The patient's condition at the conclusion of the procedure was reported to be fully recovered.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable event of a balloon leak in the esophagus.H11: investigation results: the returned cre pro wireguided dilatation balloon was analyzed, and a visual inspection found that only the unopened original pouch was returned.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon leak was not confirmed.Due to lack of evidence and without proper evaluation of the device, the investigation determined the most probable root cause is cause not established.

• Brand Name: CRE PRO
• 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: 23813330
• Report Number: 3005099803-2025-06723
• Device Sequence Number: 9409641
• Product Code: FGE
• UDI-Device Identifier: 08714729797531
• UDI-Public: (01)08714729797531(17)280827(10)37323953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K112994
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/15/2026

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: M00558650
• Device Catalogue Number: M00558650
• Device Lot Number: 0037323953
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2025
• Supplement Date Received by Manufacturer: 01/05/2026; 03/19/2026
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 01/21/2026; 04/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/28/2025
• 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