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

Model Number	M00558600
Medical Device Problem Codes	Burst Container or Vessel (1074); Material Puncture/Hole (1504); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/10/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block e1: (b)(6).Block h6: imdrf device code a0402 captures the reportable event of balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dase dilatation balloon was attempted to be used in the bile duct during a endoscopic retrograde cholangiopancreatography (ercp) procedure for a tumor performed on (b)(6) 2026.During the procedure, the balloon was found to be ruptured when the balloon was used.No further information has been obtained despite good faith efforts.The procedure was completed with another of the same device.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 facility name is (b)(6); reported here as the facility name exceeded character limit for designated field.Block h6: imdrf device code a0402 captures the reportable event of balloon burst.Block h11: investigation results the returned cre pro wireguided dase dilatation balloon device was analyzed, and a visual inspection found no damages.A functional inspection was performed, and the balloon was inflated without any problem; however, it was not able to hold the pressure due to a pinhole in the balloon, located approximately at 68 mm from the tip of the device.Microscope inspection confirmed the presence of a pinhole.No other problems with the device were noted.With all available information, boston scientific concludes the reported event of balloon burst was not confirmed.The pinhole problem found could have been interpreted by the customer as the reported event of balloon burst.The results of the analysis performed on the returned device found that the balloon was inflated without any problem; however, it was not able to hold the pressure due to a pinhole in the balloon, located approximately at 68 mm from the tip of the device.It is possible that the pinhole found in the balloon 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/previous the procedure, could have caused the failure found on the distal section of the balloon.Based on a thorough review of the reported complaint, boston scientific has assigned an investigation conclusion code of 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 pro wireguided dase dilatation balloon was attempted to be used in the bile duct during a endoscopic retrograde cholangiopancreatography (ercp) procedure for a tumor performed on (b)(6) 2026.During the procedure, the balloon was found to be ruptured when the balloon was used.No further information has been obtained despite good faith efforts.The procedure was completed with another of the same device.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: 24563758
• Report Number: 3005099803-2026-00895
• Device Sequence Number: 9330914
• Product Code: FGE
• UDI-Device Identifier: 08714729797487
• UDI-Public: (01)08714729797487(17)280110(10)35598988
• 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): 04/20/2026

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: 0035598988
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/11/2026
• Supplement Date Received by Manufacturer: 03/26/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 04/20/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/10/2025
• 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: 89 YR
• Patient Sex: Female
• Patient Weight: 55 KG