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

Model Number	M00558680
Medical Device Problem Codes	Use of Device Problem (1670); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/11/2025
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 duodenum during a biliary dilatation procedure performed to treat dilation assisted stone extraction (dase) on (b)(6) 2025.During preparation, the nurse noticed that the balloon was not maintaining pressure and after they checked they found that the balloon has a defect.Additional clarification to determine the nature of the damage was not provided and the balloon may have burst.The procedure was completed with another cre pro wireguided dilatation balloon.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 pre-inflated outside of the patient.
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 a04 captures the reportable event of a balloon damage.
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 duodenum during a biliary dilatation procedure performed to treat dilation assisted stone extraction (dase) on (b)(6) 2025.During preparation, the nurse noticed that the balloon was not maintaining pressure and after they checked they found that the balloon has a defect.Additional clarification to determine the nature of the damage was not provided and the balloon may have burst.The procedure was completed with another cre pro wireguided dilatation balloon.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 pre-inflated outside of the patient.
Additional Manufacturer Narrative
A2: patient's exact age is unknown; however, it was reported that the patient was over the age of 18.H6: imdrf device code a04 captures the reportable event of a balloon damage.H11: investigation results: the returned cre pro wireguided dilatation balloon was analyzed and a visual inspection found no physical damage.A functional evaluation found the balloon inflated without problems but was not able to hold pressure due to a pinhole in the balloon.Microscopic evaluation found the balloon had a pinhole located approximately 60 mm from the tip of the device.No other problems with the device were noted.With all the available information, boston scientific (bsc) concludes the reported event of balloon damaged/defective was confirmed.The returned device was inflated without problems however it was not able to hold pressure due to a pinhole located approximately 60 mm from the tip of the device.It is possible that the pinhole found on the balloon occurred due to procedural factors such as excess pressure or interaction with other devices.Also, it is possible that interaction with a sharp surface during or previous to the procedure could have caused the pinhole.Therefore, the most probable root cause is adverse event related to procedure.A labeling review was performed and from the information available, this device was inconsistently used per the instructions for use (ifu)/product label.

• 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: 22162021
• Report Number: 3005099803-2025-02471
• Device Sequence Number: 7484780
• Product Code: FGE
• UDI-Device Identifier: 08714729797562
• UDI-Public: (01)08714729797562(17)270909(10)34806119
• Combination Product (Y/N): N
• Initial Reporter Country: IS
• 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): 08/08/2025

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: 0034806119
• 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: 05/12/2025
• Supplement Date Received by Manufacturer: 07/18/2025
• Initial Report FDA Received Date: 06/06/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/09/2024
• 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