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

Model Number	M00558690
Medical Device Problem Codes	Inflation Problem (1310); Nonstandard Device (1420); Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was attempted to be used in the esophagus during a dilatation procedure to treat stenosis performed on (b)(6) 2026.Prior to the procedure, they noticed a defect and decided to test it outside, where they noticed that it was not inflating.The procedure was completed with another of the same device.There were no patient complications reported as a result of this event.Note: the instructions for use (ifu) indicate that this balloon should not be pre-inflated prior to use in the procedure.However, the customer reported that the balloon was tested outside the patient during preparation.This event has been deemed reportable based on the investigation results: balloon pinhole.Please see block h10 for full investigation details.
Additional Manufacturer Narrative
Block h6: imdrf device code a041001 captures the investigation results of balloon pinhole.Block h11: investigation results the returned cre pro wireguided dilatation balloon was analyzed, and a visual examination found that the guidewire lumen was damaged.Functional inspection was performed, 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 problem to inflate, located approximately 75 mm from the tip.Microscopic evaluation confirmed both the pinhole and the kink in the inner sheath.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon problem to inflate was confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 75 mm from the tip of the device.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 problem found on the distal section of the balloon.Additionally, device analysis identified damage to the guidewire lumen in the balloon section, consistent with a kink.This damage is likely attributable to mechanical stresses related to procedural or operational factors, such as physician handling or technique, occurring before or during the procedure.Therefore, the most probable root cause is 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: 24434138
• Report Number: 3005099803-2026-00713
• Device Sequence Number: 16026795
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: (01)08714729797579(17)280117(10)35651316
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• 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
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• 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: M00558690
• Device Catalogue Number: M00558690
• Device Lot Number: 0035651316
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/05/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/30/2026
• Initial Report FDA Received Date: 02/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/17/2025
• 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: 46 YR
• Patient Sex: Female