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

Model Number	M00558690
Medical Device Problem Codes	Burst Container or Vessel (1074); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/09/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled procedure.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during an esophageal dilation procedure performed on (b)(6) 2025.During the procedure, the dilation balloon ruptured when reaching 6 atm.The device was removed and the procedure was not completed.No further information has been obtained despite good-faith efforts.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 stable.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used during an esophageal dilation procedure performed on (b)(6) 2025.During the procedure, the dilation balloon ruptured when reaching 6 atm.The device was removed and the procedure was not completed.No further information has been obtained despite good-faith efforts.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 stable.
Additional Manufacturer Narrative
Block a2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Imdrf impact code f1001 captures the reportable event of cancelled/rescheduled procedure.Block h11: investigation results the returned cre pro wireguided dase dilatation balloon was analyzed, and a visual evaluation found the balloon was detached from the catheter.The detached balloon was not returned.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon burst was not confirmed because the detached balloon was not returned.The investigation revealed that since the detached balloon was not returned a functional inspection could not be performed and it was not possible to determine if the balloon burst.A balloon detachment is procedure-related because it occurs as a direct result of conditions of the procedure.Therefore, the most probable root cause is an adverse event related to procedure.

• 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: 22812997
• Report Number: 3005099803-2025-03994
• Device Sequence Number: 12197217
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: (01)08714729797579(17)270509(10)33996817
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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: Other,Foreign,Health Professional,Company Representative,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/02/2025

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: M00558690
• Device Catalogue Number: M00558690
• Device Lot Number: 0033996817
• 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: 07/24/2025
• Supplement Date Received by Manufacturer: 11/14/2025
• Initial Report FDA Received Date: 08/15/2025
• Supplement Report FDA Received Date: 12/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/09/2024
• 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