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

Model Number	M00558690
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	12/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable investigation results of balloon burst.Block h11: (investigation results): the returned cre pro wireguided dilatation balloon was analyzed and a visual and microscopic evaluation noted that the balloon burst (which produces the reported leak).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 returned balloon was found to be burst (which produces the reported leak).The balloon burst is likely to have occurred due to factors encountered during the procedure such as excess pressure, interaction with other devices, or anatomical conditions.Additionally, it is possible that interaction with a sharp surface during or previous to the procedure, could have caused the problem found on the balloon.Therefore, the most probable root cause is an adverse event related to procedure.A labeling review was performed and, from the information available, this device was used per the instructions for use (ifu) / product label.
Event or Problem Description
It was reported to boston scientific corporation that a cre pro wireguided dilatation balloon was used during a colonoscopy procedure performed on (b)(6) 2024.During the procedure, it was noted that the balloon leak.The procedure was completed with a second cre pro wireguided dilatation balloon.There were no patient complications reported as a result of this event.This event has been deemed a reportable event based on the investigation finding of device balloon burst.Please see block h11 for full investigation details.

• 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: 21464393
• Report Number: 3005099803-2025-00642
• Device Sequence Number: 8750262
• Product Code: FGE
• UDI-Device Identifier: 08714729797579
• UDI-Public: 08714729797579
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• 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): 02/25/2025

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: M00558690
• Device Catalogue Number: M00558690
• Device Lot Number: 0034681777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/06/2025
• Initial Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/21/2024
• 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