MAUDE Adverse Event Report: BOSTON SCIENTIFIC CORPORATION CRE PRO; BALLOON DILATOR

Model Number	M00558600
Medical Device Problem Codes	Burst Container or Vessel (1074); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat a common bile duct stone and yellow sclera performed on (b)(6) 2025.During the procedure, the balloon was found to be burst and leaking liquid during dilation of the papilla.It was reported that the balloon burst at 6mm, but no piece of the balloon detached inside the patient.The procedure was completed with another cre wireguided dilatation balloon.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 e1: initial reporter address is no.(b)(6).Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Additional Manufacturer Narrative
Block e1: initial reporter address is no.(b)(6); reported here as the initial reporter address exceeded the character limit for the designated field.Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: investigation results the returned cre pro wireguided 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 64 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 burst was not confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 64 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.A review of the device history record (dhr) was performed.The review of the dhr identified that there were no process related non-conformances, scrap, or rework performed during the production that could explain the event.The reviews ensure each device meets specification prior to release for use.There is no indication the device manufacturing process contributed to the reported complaint.
Event or Problem Description
It was reported to boston scientific corporation that a cre wireguided dilatation balloon was attempted to be used in the duodenal papilla during an endoscopic retrograde cholangiopancreatography (ercp) procedure to treat a common bile duct stone and yellow sclera performed on (b)(6) 2025.During the procedure, the balloon was found to be burst and leaking liquid during dilation of the papilla.It was reported that the balloon burst at 6mm, but no piece of the balloon detached inside the patient.The procedure was completed with another cre wireguided dilatation balloon.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.

• Brand Name: CRE PRO
• Common Device Name: BALLOON DILATOR
• 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: 24053146
• Report Number: 3005099803-2026-00178
• Device Sequence Number: 18465018
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: (01)08714729797487(17)280108(10)35584241
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2026

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: M00558600
• Device Catalogue Number: M00558600
• Device Lot Number: 0035584241
• 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: 12/19/2025
• Supplement Date Received by Manufacturer: 04/06/2026
• Initial Report FDA Received Date: 01/13/2026
• Supplement Report FDA Received Date: 04/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/08/2025
• 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 Age: 72 YR
• Patient Sex: Male
• Patient Weight: 62 KG