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

Model Number	M00558680
Medical Device Problem Codes	Leak/Splash (1354); Use of Device Problem (1670)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/27/2025
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 during an esophagogastroduodenoscopy (egd) with dilatation procedure performed on (b)(6) 2025.During the procedure, the cre balloon leak.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.The anatomy location was reported to be the esophagogastroduodenoscopy (egd) and is being reported as it may have occurred in the esophagus.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.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable investigation result of balloon leak.The anatomy location was reported to be the esophagogastroduodenoscopy (egd) and is being reported as it may have occurred in the esophagus.
Additional Manufacturer Narrative
Block h6: imdrf device code a0504 captures the reportable investigation result of balloon leak.The anatomy location was reported to be the esophagogastroduodenoscopy (egd) and is being reported as it may have occurred in the esophagus.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 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 leak, located approximately 14 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 leak was confirmed.The analysis on the returned device found that the balloon had a pinhole located approximately at 14 mm from the tip of the device.Inflating the balloon previously can cause the balloon to lose its original shape causing resistance when inserting it into the scope and can cause pinhole found on the device.Therefore, the most probable root cause is failure to follow instructions.
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 esophagogastroduodenoscopy (egd) with dilatation procedure performed on (b)(6) 2025.During the procedure, the cre balloon leak.It was reported that no piece of the balloon detached inside the patient.The procedure was completed with another cre pro wireguided dilatation balloon.The anatomy location was reported to be the esophagogastroduodenoscopy (egd) and is being reported as it may have occurred in the esophagus.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.

• 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: arlene acevedo gutierrez ; 300 boston scientific way; marlborough, MA 01752 ; 7877968283
• MDR Report Key: 21665476
• Report Number: 3005099803-2025-01146
• Device Sequence Number: 18058010
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: 08714729797562
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• 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,Followup
• Report Date (Section B): 05/30/2025

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: M00558680
• Device Catalogue Number: M00558680
• Device Lot Number: 0034103480
• 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: 02/27/2025
• Supplement Date Received by Manufacturer: 05/08/2025
• Initial Report FDA Received Date: 03/21/2025
• Supplement Report FDA Received Date: 05/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/24/2024
• 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: Female