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

Model Number	M00558920
Medical Device Problem Code	Burst Container or Vessel (1074)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/18/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the biliary tract during an endoscopic biliary stone removal procedure performed on (b)(6) 2024.During the procedure, the balloon size immediately decreased, after pressurizing and inflating the balloon.The procedure was completed with another cre rx dilatation balloon.No further information has been obtained despite good faith efforts.The reported event may suggest that the balloon burst during the procedure.There were no patient complications reported as a result of this event.
Additional Manufacturer Narrative
Block h6: imdrf device code a0402 captures the reportable event of a balloon burst.Block h11: the returned cre rx dilatation balloon was analyzed, and a visual and microscopic inspection found no problem with the device.Functional inspection was performed, the balloon was inflated, and it was able to hold the pressure without any problem.No other problems with the device were noted.With all the available information, boston scientific concludes the reported event of balloon burst was not confirmed.The device returned has no visible problem, and after a functional inspection the balloon was able to be inflated and maintain its pressure without any problem.Therefore, the most probable root cause is no problem detected.
Event or Problem Description
It was reported to boston scientific corporation that a cre rx dilatation balloon was attempted to be used in the biliary tract during an endoscopic biliary stone removal procedure performed on (b)(6) 2024.During the procedure, the balloon size immediately decreased, after pressurizing and inflating the balloon.The procedure was completed with another cre rx dilatation balloon.No further information has been obtained despite good faith efforts.The reported event may suggest that the balloon burst during the procedure.There were no patient complications reported as a result of this event.

• Brand Name: CRE RX
• 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: 21128747
• Report Number: 3005099803-2025-00035
• Device Sequence Number: 7517092
• Product Code: FGE
• UDI-Device Identifier: 08714729965473
• UDI-Public: 08714729965473
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K172520
• 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): 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: M00558920
• Device Catalogue Number: M00558920
• Device Lot Number: 0034075281
• 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: 12/18/2024
• Supplement Date Received by Manufacturer: 02/03/2025
• Initial Report FDA Received Date: 01/10/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/21/2024
• 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